Volume 19, Number 2

June 2010

• Please REGISTER NOW! Announcing the 4th Annual CARES Conference
• ORBIS Trip to Ethiopia
• Goodbye Joan and Welcome Mary
• Clinical Research - A Side Line View
• Meet Lorraine Miller - Chat Room Volunteer
• Meet Elizabeth L. Affel, MS, OCT-C –Technical Director of the Wills Eye Diagnostic Testing Center
• The Glaucoma Service Foundation is now on PayPal!
• Donors (Download PDF)

Please REGISTER NOW! Announcing the 4th Annual CARES Conference

The single-most important thing a person can do to remain healthy, or at any rate not to get worse, is to care for himself or herself well. Caring for one’s self requires practical knowledge and development of healthy habits and practices. Good self-care requires, also, knowing what facilities are available and then using them appropriately. Providing people with practical, useful information that will help them remain healthy, or at the least not get worse, is what the CARES Conference is all about. There are few events like it. We invite you to come and believe you will find it enjoyable and conducive to health!

Since January 2007, the Glaucoma Service Foundation to Prevent Blindness at Wills Eye Institute has held a day long conference called the “CARES Conference.” CARES stands for “Committed to Awareness through Research, Education, and Support.”

This is a patient directed educational conference about glaucoma. Last year, over 170 patients and their families from around the United States (primarily Pennsylvania, New Jersey, Delaware, and New York) attended this conference at Wills Eye Institute.

The event includes lectures given by Wills Eye glaucoma physicians. Free screenings for glaucoma are offered and encouraged. In addition, education resources and information are available at the CARES Conference to patients living with glaucoma.

Representatives from pharmaceutical companies with patient assistance programs, Low Vision Services, Associated Services for the Blind, and the Glaucoma Research Center will be on hand to answer questions and provide truly helpful, practical information and services.

The Glaucoma Service Foundation to Prevent Blindness is hosting the 4th Annual Glaucoma Service Foundation CARES Conference on Saturday, October 23rd, 2010, at Wills Eye Institute from 9:00 AM to 2:30 PM to further educate those suffering from glaucoma and those at risk.

The day will begin with a continental breakfast.

Here is the list of some of the exciting lectures that will be presented:
Doctor Do I have Glaucoma? by Dr. Spaeth; Laser iridotomy for narrow angles; by Dr. Fudemberg; Glaucoma: Looking into the future. by Dr. Katz; New glaucoma surgeries by Dr. Pro; What eye pressure is safe for me? by Dr. Niknam; Epidemiology of glaucoma by Dr. Henderer; Are some doctors better than others? by Dr. Schmidt; How does your doctor decide if your condition is deteriorating? How do we measure progression? by Dr. Moster; Limitations of eye drops by Dr. Myers

Register by: E-mailing: Rita Stern (rstern@willseye.org or Robert Kump (rkump@willseye.org) or by phone at (215) 928-3190 Website: Click here to register or volunteer.

ORBIS Trip to Ethiopia

Ethiopia. Most of us know the name. Few of us, including me, know much about Ethiopia. I knew that Ethiopia was an ancient country, one of the early, powerful Christian cultures, with magnificent early Coptic paintings. I was aware that Aida was the beautiful Ethiopian woman immortalized by Verdi’s opera, and that the country lies somewhere in the northeastern area of Africa, with areas of devastating poverty where starvation is a daily occurrence. Also, I knew it was close to Somalia, a dangerous, unstable country.

Abeba Weldegiorgis asked me to come spend time there in Addis Ababa, the capitol, and teach the Residents and the faculty. I knew nothing about the medical school or even if they had Residents in training.

After a long trip with changes in Manchester, England and Istanbul, Turkey, I arrived in Addis Ababa at 1:45 in the morning their time. A shuttle took me to the Hilton Hotel, with comfortable, modern accommodations. After a rest, later that morning Abeba picked me up and took me to her hospital. Outside the building which served as the Glaucoma Clinic was a canopied area about 50 feet by 100 feet, where perhaps 300 patients were waiting to be seen by the two fulltime glaucoma faculty, and the Residents assigned to the Glaucoma Service. The patients were dressed quite formally, most of wearing simpler farm clothes. The women showed more diversity, about half wearing long white dresses reaching to the ground, often with some colored ornamentation, others long draped dresses of bold brilliant colors, and all of them with headscarves. In about one-third of the cases these were similar to those worn by Muslims. The people in Addis are largely Christians, and the Greek Orthodox Church is massive, and always surrounded by hundreds and hundreds and hundreds of the devout, kneeling, kissing the ground, quietly saying prayers individually nestled against the church, or lighting candles.

In the room into which the patients first came was a technician, measuring intraocular pressures using a Schiotz tonometer, and a Resident examining patients at a desk.

In the next room was another technician, about five chairs along one side of the wall, and on the opposite side two slit lamps, one for the Resident and one for the faculty.

Abeba had arranged to have me see around 30 patients that morning, to select which ones I thought would be appropriate for surgery. In almost all cases, I agreed with her choice of who needed surgery and what surgery should be done. The examining equipment was functional, but barely. The Humphrey Perimeter did not work because the printer could not be repaired. There was no imaging equipment. I was intrigued to note something which I have observed in India, Egypt and other areas, including some Latin American countries. Specifically, my method of characterizing the anterior chamber angle and optic disc is the one used by those ophthalmologists. The clinical examinations were every bit as good as those I see almost anywhere and therapeutic plans seemed on target.

On each of the following days I spoke with the Residents from 8:00 to 9:30 each morning and found them knowledgeable and responsive.

The rest of the day was spent in the operating room. The facilities were good, but difficult or impossible to maintain. The device to change the focus or to zoom in and out on the operating room microscope did not work. An impressive part of the whole experience in the operating room was the awareness of the patients that miracles were taking place in front of their eyes and on their eyes and how grateful they were to be able to be part of the process. The doctors were highly competent, focused and had excellent surgical results. The staff was competent and focused on the patient, and I heard no discussions about where the nurses would be going on their vacations or break time.

Travel can literally lead one to new places, not just geographically, but new ways of thinking and acting. We are all limited by the cultures in which we developed and exist and by the knowledge we have, which comes from our genes and our experiences. Of course it is possible to travel, even to far-away places, and yet never leave one’s own culture. In fact, that is the way many trips are specifically designed. However, this trip to Ethiopia took me to many new places, geographically, medically, intellectually and emotionally. I returned encouraged about the potential for good that can be done by people and discouraged by how often that potential is blocked by how our species has evolved, so that the “strongest” win, and the “best” are often casualties. It is sad to know that throughout Ethiopia children are malnourished, growth stunted, women suppressed, animals maltreated and people, other creatures and the environment exploited by both the weak and the strong. The soil is fertile and the opportunities for profitable agriculture great. But there is such a long history of tribal rivalry and corruptin that the country is culturally and environmentally stalled.I was tremendously favorably impressed by the good skills and the goodwill of the physicians. But leaders who use the population to support their particular and often self-promoting vision vie with each other for the hearts, minds and money of the people and the outlook for the country and its inhabitants did not seem promising.

Patient undergoing surgery                                                     Waiting room in Ethiopia

Dr. Spaeth and Dr. Abeba Weldegiorgis

Goodbye Joan and Welcome Mary

by Rob Kump

Joan Malony, our Foundation book keeper has recently announced her retirement. Over the course of the past year and a half I have had the chance to work with Joan and share an office. In that time, she has been nothing but kind and I sincerely wish her the best moving forward. Last week I sat down with Joan to ask her the following question.

“What was your favorite part of your work at the Glaucoma Service Foundation?” Joan says, “The people. They were very nice people to work with. It's also nice knowing that you're working for a non profit and helping others with glaucoma. That's kind of my nature is helping others.”

Rob Kump finalizes, “Well Joan, we wish you all the best in retirement. It has been a pleasure working with you and we will all miss you.”

Robert Kump- How long have you been doing bookkeeping?

Mary W. Lyons- I have owned and operated my own bookkeeping/ accounting service for the past 12 years.

Robert Kump- Where else have you worked? What is your background?

Mary W. Lyons- I started out with my husband’s company, Lyons Brothers Hardware and Glass Company located in Ardmore. I was brought in to my husband's Company about 16 years ago to help out after their bookkeeper retired. I was trained by Lyon Brother’s accountant on how to keep records, and especially on how to do payroll, and payroll tax filings. I left Lyons Brothers, when my son was born. When he was old enough to start school, I started my own bookkeeping business, servicing clients from my home, so that I could be at home for my three children. My first client was a non-profit organization. I was able to grow my business, by way of referrals which came from the non-profit organization that I started out with and are still my clients. I've gotten almost every other client I've had that way.

Robert Kump- How did you hear about the Glaucoma Service Foundation?

Mary W. Lyons- Rita Stern (GSF Program Director) and I have a mutual friend at the non-profit organization I am working for. That is how I heard that the Glaucoma Service Foundation was looking for someone to replace the current bookkeeper, Joan, who was planning to retire.

Robert Kump- How do you like it here so far?

Mary W. Lyons- I really like working for the foundation. I am very impressed with the work the foundation does.

Robert Kump- What are you goals to help us?

Mary W. Lyons- I would really like to use my organizational skills to help the foundation keep an accurate and up to date accounting of all funds and records.

Robert Kump- Is there anything else you'd like to say to our readers?

Mary W. Lyons- I've been given a warm reception here. I like the people, and the organization. I'm looking forward to keeping the books as the foundation grows.

Robert Kump-Welcome to the Glaucoma Service Foundation Mary and best of luck.

Clinical Research - A Side Line View

By: Sheryl S. Wizov, COA

Clinical Research is the process by which all new medications, treatments, and testing are proven to be safe and effective for general use. It requires testing human subjects with a specific set of guidelines, otherwise known as a Protocol. The Protocol is designed to answer questions that lead to better CARE for patients. Good Clinical Practices were implemented by the Food and Drug Administration in the mid 1970s to standardize the research process, to ensure accuracy and integrity of data reporting and to protect the human subjects. In other words, the field is leveled for everyone to play by the rules.

Every medication from Avandia (common diabetes medicine) to Zestril (common hypertension medicine) has gone through rigorous clinical research before receiving FDA approval for marketing and clinical use. The same holds true for devices such as tube shunts for glaucoma surgery, equipment used for testing visual fields, or the HRT, which provides measurements of the optic nerve in the back of the eye.

Pre-clinical trials look at compounds and structure then go on to animal testing before being tried in humans. Not all compounds and structures are successful in continuing on to human trials. Once pre-clinical trials look promising, four phases of clinical research begin. Phase 1 is testing a new drug or treatment in a small group of healthy people, usually young men age 18 to 34 years, for the first time to evaluate safety, determine a safe dosage range, and identify side effects. In phase 2, the drug or treatment is given to a larger group of people, typically affected by a particular disease or condition, to determine effectiveness and to further evaluate safety and dosing levels. In phase 3, larger groups of people are used to confirm effectiveness, monitor side effects, compare treatment to those commonly used, and collect information that will allow the drug or treatment to be used safely. Phase 4 studies are done after the drug or treatment has been FDA approved and marketed. This phase gathers more information on the drugs’ effects in different populations and compiles side effects associated with long-term use. That long, folded piece of paper written in tiny print which is difficult to see and even harder to understand is the Product Insert of every medication. It contains a summary of all the phases of clinical trials pertaining to that medication or device.

In 2003, doctors from Tufts Center for the Study of Drug Development reported on the cost of bringing a drug to market. Data came from 42% of all pharmaceutical research and development expenditures in the U.S. The authors found that it takes approximately 7.5 years at a cost of $802 million to take one drug from Phase 1 clinical trials to FDA approval. Keep in mind that this does not include any pre-clinical development before hand.

Research Studies take place at Wills Eye and all over the world. One day you may be approached to participate. Here is a brief description of some different types of studies. A study for a new drug, device or procedure requires rigorous investigation which may include blood work, urine samples, blood pressure and a detailed medical history. Comparison studies of drugs or devices which are already FDA approved, may not require such extensive lab work, since these issues have already been investigated in prior Phase 1-3 studies. These comparison studies investigate one treatment against another to determine which is more effective. Combination studies add two medications into one drop or drug making it more convenient and less costly for patients, and provide another marketable drug for companies. Tissue studies take samples, such as conjunctiva, the clear cellophane like coating covering the white part of the eye, to look for inflammation on the outer surface caused by eye drops. Genetic studies isolate genes in certain diseases or populations of people through the testing of DNA and RNA. They can also aid in the development of new improved medications by identifying differences and similarities in the genes. DNA may be obtained through blood testing, or sometimes just a sweep of a swab inside the mouth. Quality of Life studies measure ability to function in everyday life. Questionnaires and surveys quantify people’s perception of how well they are getting along in everyday life.

Investigator initiated studies are designed by one person from our staff, known as the Principal Investigator (PI). We are currently conducting a study, designed by Dr. Spaeth, to compare the doctors’ clinical findings with patient’s ability to perform activities of daily living in glaucoma patients. Once a doctor designs a study such as this, they must seek funding to support it.Sponsor initiated studies are designed and funded by a company who invites an investigator or group of investigators to participate. Studies may be carried out in a single location, like Wills Eye Institute, or may include any number of facilities located throughout the country in a multi-centered study.

Chronologically, studies either look back at what has occurred, or go forward by planning ahead. Retrospective studies review charts to analyze specific data. A doctor who does a fair amount of glaucoma filtering surgeries might look at all cases performed during a 5 year period for successes, complications, intraocular pressures, and number of pressure lowering medications required during the post operative period. Prospective studies involve monitoring patients and outcomes as they occur rather than looking back at past events. A hypothesis (known as a plan or question) is developed then a Protocol is written to support the hypothesis. A Protocol is a full description of the study game plan. The details include how many patients are needed, where they will come from, how they qualify, how many visits occur during the study, what takes place at each visit, what drug or device is being used, what the known benefits and risks are, how long the study will last, what the primary endpoints are, (such as intraocular pressure and visual field loss), how the data will be analyzed and how the study will be funded. Length of time for participation can last anywhere from one day to five years or whatever is needed according to the issue being investigated.

The best developed prospective studies include three basic components. First, a control group is needed, consisting of normal subjects (with no disease) or patients receiving no treatment, sometimes referred to as a placebo group. It’s important to have a control group for comparison to clearly identify a difference from the treatment group. Second, randomization is a formula that assigns patients to different groups. This process, much like flipping a coin, eliminates any bias the treating investigator may have in selecting who receives treatment and who should not. And third, masking the groups so investigators don’t know what group patients are assigned to until the final results are tabulated. This removes any influence the investigator may have in interpreting the results. When subjects are randomized and treated equally with a control group for comparison, data integrity is solid and less likely to be challenged.

Life is full of risks and benefits. Clinical research must carefully balance the two with patient safety in mind. It is unethical to design a study with a placebo if denying treatment may be harmful to patients. Studies are designed to minimize risks to subjects – either risks from not being treated, or risks from a new treatment. Study Coordinators are responsible for consenting and protecting patients during participation. Consenting requires describing every detail about participation in the study in terms that patients can clearly understand and asking for the study subject’s consent. Protecting patients is everyone’s job on the team and we take it seriously! Adverse events can and do occur during research studies but they are rare, usually mild, and not always caused by the medication or participation. That’s why all adverse events need to be documented – so that research can determine which are related to the study, and how common and serious they are. Reporting adverse and serious adverse events to appropriate groups such as the Sponsor, IRB, and FDA is vitally important no matter how unrelated they may seem to the study.

There is a subtle difference between a routine patient and a study participant. Standard of care, or routine, means the doctor treats the patient as he or she deems appropriate for the visit. In a study, the patient and doctor have agreed, in writing, to follow a precise set of guidelines for a specific number of visits. Safety of the patient is paramount, and so if needed, the subject can be withdrawn from the study to allow other treatments.

At any time participation can be terminated by the investigator or the patients can choose to withdraw on their own. A study patient volunteers their time, and may or may not benefit directly from the study. With the extra time spent with research staff, the study patient has an opportunity to increase their knowledge of the disease. Society also stands to benefit when clinical trials are reported and published for everyone to learn about.

One might think of Clinical Research as a Team Sport. Every player has his or her responsibility. The Principal Investigator is the Manager of the team with sole responsibility for the conduct on the playing field. The Sponsor, like an owner, pays the bills, in most cases. The Institutional Review Board of Wills Eye approves the studies conducted here, much like a referee. They are responsible for protecting the community at large. Data and Reading Centers receive the information obtained from the study for analysis. They keep statistics to gauge game performance. Monitors check the integrity and validity of the information to ensure the statistics are reliable and usable. The Clinical Coordinator is responsible for the day to day operation of all details associated with the conduct of the study and works closely with the study participants much like the Coach does with the players, coaching staff, sponsors and monitors. It’s the coordinators responsibility to make sure every one plays by the rules. And finally we have the players, better known as the Study Participants. If a study has two groups, one group might receive treatment and the other may not receive treatment. The group receiving no treatment, known as the control group, provides comparison data for the treatment group. Team players don’t always benefit by their participation, somewhat like sitting on the bench. Participation is vital to the team no matter what group they are assigned to or what position they play.

In every sport, the entire team must work together effectively to ensure a good effort, or in our case, a well conducted study. The score may not reflect what everyone had in mind, but in the end, the study did what it set out to do, play by the rules to the best of our ability.

With a well organized game plan (Study Protocol), and committed players in place (investigator, sponsor, coordinator, monitor and patient), the outcome is sure to be a winner. If you or someone you know may be interested in trials taking place in the Glaucoma Research Center at Wills Eye Institute, feel free to contact Jeanne Molineaux @ 215-825-4713 (jmolineaux@willseye.org), Marianne Steele @ 215-928-3204 (msteele@willseye.org) or Sheryl Wizov @ 215-928-3221
(swizov@willseye.org).A thorough eye exam with one of our glaucoma physicians is necessary to evaluate your eligibility for research studies, and this may or may not be covered by your medical insurance.

Studies in Recruiting Phase

1) Ocular Surface Changes – This study is comparing how two standard medications affect the outside of the eye such as irritation, redness and inflammation. It also compares patients’ comfort level and preference. The medications used are Xalatan and Travatan Z. Patients who qualify are those new to treatment or only on Xalatan.
2) Avastin in Bleb Needling – This study investigates Avastin (Bevacizumab), a medicine to stop new blood vessels from forming, in conjunction with traditional anti scarring medication, Mitomycin C, used during surgery. Patients who qualify are those requiring surgery to revise the original glaucoma surgery by separating scar tissue which formed around the wound, clogging up the new drain.
3) Triesence in Glaucoma Surgeries – This study looks at Triesence (Triamcinolone), a corticosteroid used during surgery to reduce inflammation during the post operative period. Patients requiring any type of glaucoma surgery may qualify.
4) SPARCS – Validation and reproducibility of Spaeth/Richman Contrast Sensitivity Test
5) Brain Imaging – The purpose of this study is to determine if glaucoma is associated with changes in areas of the brain other than the areas where vision is processed.

This will help guide the direction of further research in the use of neuroprotective agents in preventing or controlling such changes. The goal is to improve the quality of life for patients with glaucoma. Patients who qualify are those who participated in the Assessment of Ability Related to Vision Study.

Meet Lorraine Miller - Chat Room Volunteer

By: Rita Stern

Stern: How long have you been volunteering in the Chat Room?

Miller: Two years in June. I sent Vivian, the webmaster, an email and asked if I could help.

Stern: What do you enjoy most about your volunteer work?

Miller: I enjoy helping others with finding answers to their glaucoma problems as I did through the site. I really believe I gain more from the experience than I give.

Stern: What inspired you to volunteer in the chat room?

Miller: Nine years after being diagnosed, I was sent to a glaucoma specialist, Dr. Robert Barnes. At the end of our initial visit, he told me that I did not understand how serious my glaucoma was for my age. He was right, I didn’t. I didn’t know much about the disease at all. I found the Wills site through a general search, read the archives, the Bionic Eye and began attending chats. Two years ago, Dr. Barnes told me I was the most educated patient he had. Wills provided me the knowledge to elicit his comment.

Stern: What are your roles in the chat room?

Miller: I develop the questions for the chat. Many doctors do not have time to answer a dozen questions a patient may ask at each
visit. I try to cover the basic questions a newly diagnosed patient might have about the topic so a patient can ask more personalized, in-depth questions of their physician. I also use questions I had asked my own doctor. If I experience a glaucoma problem and I cannot find answers in the archive, I suggest the topic to Vivian for a future chat.

Stern: What is your background?

Miller: I am a glaucoma patient living in the Chicagoland area. The internet allows us to reach beyond our geographical area. I have no medical background, just a desire to learn.

Stern: Do you see yourself continuing to volunteer in the chat room for many more years?

Miller: I hope the chat room exists longer than I do! Patients throughout the world have the benefit of Dr. Pro’s time and answers. Many times he provides answers more in-depth than the article from which the question was derived. He has the ability to explain and teach in simplistic terms while providing detail to his answers. I hope Dr. Pro’s involvement continues in the moderated chats for many more years.

Stern: I heard that you participated in the American Glaucoma Society's Patient Care Improvement Project in 2006. Please tell me about your experience with Dr. Wilson and how he helped you.

Miller: I received an award from the American Glaucoma Society’s Patient Care Improvement Project with my suggestion of patients dating the bottom of their eye drop bottles using a permanent marker with the date opened to document how long a bottle lasts them. A patient then has a better idea of when to renew a prescription. I flew to Las Vegas to accept the award and because Dr. Wilson would be present. I had asked Dr. Wilson many questions for a year and a half about glaucoma in the moderated chat. I compared his answers with the answers I asked my own doctor to see if they both would provide me with the same answer. Dr. Wilson was always very open, honest and detailed in his responses to my questions. He helped me through my trabeculectomy and then post-op.

I wanted Dr. Wilson to know the impact he had on my life even though I was not a patient of his. I appreciated the time he took each week to answer questions that I knew he heard a hundred times before from his own patients. I just wanted to thank him.

Stern: Is there anything else you want to share with our readers?

Miller: Yes I do. I am the patient in http://www.willsglaucoma.org/edu/typicaltrab.htm.

The chat room entrance screen asks the individual to sign in with a nickname to connect. Mine is Misty, my dog.

Meet Elizabeth L. Affel, MS, OCT-C –Technical Director of the Wills Eye Diagnostic Testing Center

By: Rita Stern

Stern: How long have you been working at the Diagnostic Center?

Affel: The Diagnostic Center opened in July of 2009. Previously, we had two departments, GSDL, the Glaucoma Service diagnostic Laboratory and the Visual Physiology and Ultrasound departments. We have combined the testing, staff and purchased new equipment so we are able to perform testing for the entire ophthalmic community. We are also certified for research studies by the Reading Centers.

Stern: Please describe briefly a typical day?

Affel: We often start at 7:00AM testing in the preoperative area in the Operating Rooms of the Wills Eye Ambulatory Surgical Center or the Jefferson Hospital for Neuroscience. Our scheduled patients begin testing at 7:45 AM, and we continue to see patients, both scheduled and emergencies throughout the day. Our staff is staggered to accommodate most needs.

Stern: How many employees are there?

Affel: We have three employees in the registration area, who register the patients, take insurance information, check for written orders, and answer the phone.We have five full time technicians, including myself, and two part time employees, one of whom is a co-op student.

Stern: What do you love most about your job?

Affel: I love teaching: technicians, residents, and fellows. I love sharing my knowledge and enthusiasm for ophthalmic imaging.

Stern: What is the role of your department?

Affel: The role of the Diagnostic Testing Center is to provide quality state of the art testing on patients for all of the physicians at Wills Eye and in our community. Some of the tests we perform are not available in a general practice setting, so patients come from all over the Tristate area for testing.

Stern: Why would someone need to use your services?

The Glaucoma Service Foundation is now on PayPal!

Please click here to make a contribution right from your computer.

CHAT SUPPORT GROUP

1st and 3rd Wednesday of the month 8:30 – 9:30 pm
Hosted by a Wills Glaucoma Specialist

Mondays, 8:00-9:30 pm

Saturday, 10:00 am

Patients and family members only

Current and archived chat highlights are available for review on our website www.willsglaucoma.org If you do not have access to a computer, call the Foundation to have a printed copy mailed to you.