Retinal branch vein occlusion (BVO) is the second most common retinal vascular disease after diabetic retinopathy. Many treatments for this disorder were attempted before 1977, but none were proven to be effective. The only treatment that seemed at all promising in preventing visual loss from BVO was laser photocoagulation.

Approximately 500 patients were enrolled in the study. One-half were randomly assigned to treatment with argon laser photocoagulation; the other one-half remained untreated as controls. For BVO with or without neovascularization, scatter treatment of 100 to 400 laser burns was applied in the drainage area of the occluded vein site, avoiding the fovea and optic disc. Individual laser burns were 200 to 500 microns in diameter with an exposure time of 0.1 to 0.2 seconds. For macular edema, burns of 50 to 100 microns in diameter with exposure time of 0.05 to 0.1 seconds were used. A fluorescein angiogram less than 1 month old had to have been available for each patient. Treatment was performed under topical anesthesia using the argon laser to achieve a grid pattern over the area of capillary leakage identified by fluorescein in the macular region. Photocoagulation was extended no closer to the fovea than the edge of the foveal avascular zone and did not extend peripherally beyond the major vascular arcade. The efficacy of treatment was judged on the basis of visual acuity measurements as well as assessment of the subsequent development of neovascularization and/or vitreous hemorrhage. Patients were followed for at least 3 years.

Patients with three types of diagnoses were accepted:
(1) major BVO without neovascularization;
(2) major BVO with neovascularization;
(3) BVO with macular edema and reduced vision.
All patients must have had onset of signs and/or symptoms of BVO less than 18 months before the initial visit, vision of 5/200 or better, and sufficient clarity of the ocular media to permit confirmation of the condition with fundus photography. Other eligibility criteria apply to each of the three major groups as well as special cases such as the occurrence of bilateral disease.

No longer recruiting. Comments: Patient recruitment began in July 1977 and ended in February 1985.

Completed, with results published. Comments: Completed.

Results from this 8-year study indicated that use of argon laser photocoagulation can benefit those afflicted with certain types of BVO, a retinal vascular disease that is second only to diabetic retinopathy in frequency.
The results indicated that argon laser treatment improves sight significantly in patients who already have reduced vision due to a complication of BVO called macular edema, or swelling (the macula is the area in the retina used for sharp focusing and fine details). In addition, laser will significantly reduce the likelihood of vitreous hemorrhage.
The proven effective use of laser in treatment of BVO was especially significant because the retina cannot be replaced or transplanted if damaged by the condition.

Amblyopia, or lazy eye, is the most common cause of visual impairment in children and often persists in adulthood. It is reported to be the leading cause of vision loss in one eye in the 20-70 year old age group, with a prevalence of 1-4 percent in various studies, indicating that both improved means of detection and treatment are needed.

Most of the available data on the natural history of amblyopia and success rates of its treatment with either patching or drug therapy are retrospective and uncontrolled. Despite the common occurrence of amblyopia, there is little quality data on treatment of this condition. Thus, there is much to be learned about the course of treated amblyopia, to provide more precise estimates of success rates and to identify factors that may be associated with successful and unsuccessful treatment.

Amblyopia, when diagnosed in children, is usually treated with occlusion (patching) of the sound eye. Occlusion therapy is subject to problems of compliance, due to the child’s dislike of wearing a patch for visual, skin irritation, and social/psychological reasons. There is evidence that compliance may be one of, if not, the most important determinant of success of amblyopia therapy.

An alternative treatment, drug therapy with a cycloplegic drug (atropine) that dilates the pupils and blurs the image seen by the sound eye, has been known for almost a century. This method has been widely used for the management of occlusion treatment failures and for maintenance therapy. However, it has seen little use as a primary treatment for amblyopia. Clinical experience has found that it has a high acceptability to patients and parents, and hence high compliance. In addition to its acceptability, pharmacologic therapy has the known advantage over occlusion of providing a wider visual field with both eyes, which may have safety and other functional implications. There is also clinical and laboratory evidence suggesting that drug therapy may maintain and improve the ability to see with both eyes (binocularity).

Available data suggest that the success rate with drug therapy is as good as, if not better than, the success rate with occlusion therapy for mild to moderate degrees of amblyopia. If this is true, for many children with amblyopia, drug therapy may be the preferred initial therapy since it appears to be more readily accepted by the children and parents. Despite data to support the use of drug therapy as a primary therapy for amblyopia, it has gained only limited use among pediatric ophthalmologists. A definitive study comparing the outcomes from occlusion therapy and drug therapy is justified in order to determine if new practice guidelines for treatment of amblyopia are needed.

Regardless of whether the trial determines that one therapeutic approach is better than the other, the data that are collected will provide valuable information about the course of amblyopia treatment that is not presently available. The study also is expected to provide data that will help to determine whether factors such as age, refractive status, cause of amblyopia, or fixation pattern should be considered in determining which procedure is best for a given patient.

The study is a randomized trial comparing patching and atropine therapies in the treatment of amblyopia. Patients in the patching group were initially started on 6 to 12 hours per day of occlusion; patching time was increased if the child did not improve. The atropine group received one drop of 1 percent atropine once a day. There were at least three follow-up visits for the first six months, and then at least one visit every six months until the end of two years. Visual acuity is the major study outcome. It is assessed after six months and at two years.

Extended Follow up of Study Patients
The extended follow up study consists of annual visits prior to age 10, followed by visits at age 10 years and at age 15 years. There is no amblyopia treatment that is required during the extended follow up period.

Patients must be less than 7 years old with amblyopia due to strabismus or anisometropia. Visual acuity in the amblyopic eye must be between 20/40 and 20/100, visual acuity in the sound eye or 20/40 or better, and there must be at least 3 lines of acuity difference between the two eyes. Patients must have had no more than two months of amblyopia therapy in the past two years.

No longer recruiting. Comments: Completed. Recruitment began in April of 1999 and closed in April 2001 after 419 patients were enrolled.

Completed, with results published. Comments: Completed. Six-month follow-up (primary outcome exam) was completed in November 2001. Two year follow up of patients was completed in July 2003.

Extended follow up of study patients is ongoing. Patients are still being re-consented. As of August 1, 2004 185 patients at 26 sites have re-consented to continue in follow up.

Between April 1999 and April 2001, 419 patients entered the trial, with 215 assigned to the patching group and 204 to the atropine group. The mean visual acuity in the amblyopic eye at enrollment was approximately 20/63, with a mean difference in acuity between eyes of 4.4 lines. The average age of the children was 5.3 years; 47 percent were girls and 83 percent Caucasian.

At six months, visual acuity was improved from baseline by about 3 lines of vision in both the atropine and patching groups. Improvement initially was faster in the patching group, but after six months, the difference in acuity between treatment groups was small. The mean visual acuity (Snellen approximation) at six months was 20/32 in the patching group and 20/32^-2 the atropine group. This small difference between groups was considered clinically inconsequential.

Both treatments were well tolerated, although atropine had a slightly higher degree of acceptability on a parental questionnaire. More patients in the atropine group than in the patching group had reduced acuity in the sound eye at six months but this did not persist with further follow up.

Both atropine and patching are effective treatments for moderate amblyopia in children in the age range of 3 to less than 7 years old. Patching has the potential advantage of a more rapid improvement in visual acuity and possibly a slightly better acuity outcome, whereas atropine has the potential advantage of easier administration and lower cost. Our data are inconclusive about whether atropine may cause a transient treatment-related reduction of acuity in the sound eye more often than does patching. However, we are reasonably confident that in our cohort atropine did not have a lasting adverse effect on acuity of the sound eye. Since incomplete responders to one treatment could later be given the other treatment, our results indicate that the initial choice of patching or atropine can be made by the eye care provider and parent. Both patching and atropine are appropriate treatment modalities for the initial management of moderate amblyopia in children.

Two year follow up data is not available at this time. Manuscript submitted to Archives of Ophthalmology in January 2004.

Cataract is one of the most common causes of impaired vision as well as the third leading cause of blindness in the United States. Cataract surgery is one of the safest and most successful of all operations. The National Eye Institute has estimated that if the progression of cataract could be slowed enough to delay the need for surgery by even 10 years, the current annual number could be reduced by 45 percent.

Little is known about the relative importance of various potential risk factors in the development of cataract. Most current information on risk factors has come from anecdotal reports or from relatively small case-control studies. One major project, the Framingham Eye Study, has identified several factors that were significantly associated with subsequent cataract formation, including diabetes and dietary factors. Diabetes has long been thought to increase the risk of developing cataract.

Recently, aspirin has been proposed as a drug that can prevent cataract formation or slow its progression. Aspirin may affect tryptophan levels in patients with cataract, or it may inhibit aldose reductase, an enzyme associated with the development of diabetic cataract. Thus, data from this study sought to determine whether one 325-mg aspirin tablet, taken on alternate days, protects against cataract formation. The data also sought to reveal other additional cataract risk factors that emerge after simultaneous controlling for other variables.

The other primary objective of this trial was to assess the antioxidant effects of beta-carotene (50 mg on alternate days) on cataract development. In addition, factors that have been suggested to be cataractogenic were assessed in prospective cohort studies. These factors included age, blood pressure, blood cholesterol, height, diabetes, medication use, cigarette smoking, and history of previous eye trauma or surgery. In addition, the possible associations between history of vitamin E and selenium intake and cataract were explored.

This trial was part of the Physicians’ Health Study, an ongoing, randomized, placebo-controlled clinical trial of aspirin in the prevention of cardiovascular mortality and of beta-carotene in the prevention of cancer. Following randomization, each of the 22,071 physicians enrolled was assigned to one of four groups to take either aspirin or its placebo and beta-carotene or its placebo. Follow-up questionnaires were sent 6 and 12 months after randomization and every 12 months thereafter. The randomized aspirin component of the trial was terminated early (January 1988), after an average followup of approximately 5 years, because of a statistically extreme 44 percent reduced risk of a first myocardial infarction in the aspirin group.

Since this study is conducted by mail among physicians nationwide, examinations cannot be performed on all patients to determine when they have reached an end point. Reported diagnoses of cataract are confirmed by medical record review. The primary analysis will be of incidence of cataract in the aspirin and placebo groups. In addition, the Cox proportional hazards model will be used to determine whether there is a difference in time to cataract diagnosis between the two groups. It has been postulated that the potent antioxidant properties of beta-carotene might make it effective in preventing cataract development. The investigators will thus determine whether there is a difference in the numbers of cataracts between the beta-carotene/placebo groups and the aspirin/placebo groups.

The study population consisted of 22,071 male U.S. physicians, aged 40 to 84 years in 1982, with no history of myocardial infarction, cancer, kidney disease, renal disease, or any other contraindication to the use of aspirin or beta-carotene, including regular use of corticosteroids.

No longer recruiting. Comments: Recruitment began in April 1982 and was completed in December 1984.

Completed, with results published. Comments: Completed. This study was terminated in January 1988.

There were 173 age-related cataracts among those physicians assigned to aspirin therapy and 180 among those given placebo (relative risk, 0.95; 95 percent confidence interval, 0.74 to 1.22). Cataract extractions were less frequent in the aspirin group than in the placebo group, but this difference was not statistically significant (relative risk 0.80; 95 percent confidence interval, 0.56 to 1.15). Among younger men (aged 40 to 59 years), the relative risks were 0.62 (95 percent confidence interval, 0.40 to 0.94) for cataract development and 0.67 (95 percent confidence interval, 0.38 to 1.31) for cataract extraction.

These randomized trial data tend to exclude any large benefit of aspirin. While the overall findings concerning cataract development seem to be null, the data on extraction of age-related cataract, while not statistically significant, cannot exclude possible small-to-moderate benefit of alternate-day aspirin therapy on the extraction of age-related cataract.

To assess the long-range outcomes of sequences of interventions involving trabeculectomy and argon laser trabeculoplasty in eyes that have failed initial medical treatment for glaucoma.

In advanced glaucoma, medication alone no longer reduces intraocular pressure adequately, and the eye has field defects. Before 1980, some type of filtering surgery, such as trabeculectomy, was the usual method of intervention. Since then, laser trabeculoplasty has become a popular alternative. Sometimes the first intervention chosen succeeds in controlling pressure for many years; at other times, the success lasts only a few weeks or months. Because success is limited, some patients, over time, need to undergo a sequence of surgical interventions. Little is known about which sequence gives the best long-range outcome.

The Advanced Glaucoma Intervention Study (AGIS) is designed to provide a comprehensive assessment of the long-range outcomes of medical and surgical management in advanced glaucoma. The study uses visual function status to compare two intervention sequences in managing the disease.

Eligible eyes are randomly assigned to one of two intervention sequences: (1) trabeculectomy, followed by argon laser trabeculoplasty (ALT) should trabeculectomy fail, followed by a second trabeculectomy should ALT fail; or (2) ALT, followed by trabeculectomy should ALT fail, followed by another trabeculectomy should the first trabeculectomy fail. Antifibrotic agents may be used as an adjunct to trabeculectomy, but only in eyes with a previous history of invasive surgery. Eyes that fail the entire assigned sequence of interventions are managed at the discretion of the AGIS physician in collaboration with the patient.

Interventions are supplemented with medical treatment as needed. A total of 789 eyes with advanced glaucoma have been enrolled. All patients are being followed under a standardized protocol for a minimum of 5 years to determine degree of visual function loss, failure rates of interventions, rates of complications, and need for supplemental therapy.

After the initial intervention, followup examinations are scheduled at 1 week, 4 weeks, 3 months, 6 months, and every 6 months thereafter. After second and third interventions, followup examinations are scheduled at 1 and 4 weeks. Additional visits are scheduled as necessary for the management of the disease.

The primary outcome variable in AGIS is average percent of eyes with decrease of vision, where decrease of vision is a substantial decline of either visual field or visual acuity attributable to the effect of glaucoma. Secondary outcome variables include sustained decrease of vision, failure of interventions, number of prescribed glaucoma medications, and level of intraocular pressure. An ancillary study is assessing filtering bleb encapsulation.

Men and women between the ages of 35 and 80 with open-angle glaucoma that was not successfully controlled by medication were eligible for enrollment.

No longer recruiting. Comments: Completed. Recruitment began in April 1988 and closed in November 1992 after 789 eyes of 591 patients were enrolled.

Ongoing. Comments: Ongoing. Followup of patients continues.

After seven years of follow-up on these patients enrolled in the AGIS, results revealed that blacks and whites differed in the way they benefited from the two treatment programs. The vision in eyes of black patients with advanced glaucoma tended to be better preserved in the program that started with the laser surgery. From initial treatment through seven years of follow-up, the average percent of eyes in black patients with decrease of vision was 28 percent in the program starting with laser surgery, as compared with 37 percent in the program starting with a trabeculectomy.

Through the first four years, the vision in eyes of white patients with advanced glaucoma tended to be better preserved in the program starting with laser surgery. Thereafter, however, the reverse was true; seven years after the initial treatment, the average percent of eyes in white patients with decrease of vision was 31 percent in the program starting with a trabeculectomy, as compared with 35 percent in the program starting with laser surgery.

Based on the study results, it is recommended that black patients with advanced glaucoma begin a treatment program that starts with laser surgery, which is consistent with current medical practice. In contrast, white patients with advanced glaucoma who have no life-threatening health problems should begin a treatment program that starts with trabeculectomy. This recommendation is inconsistent with current medical practice."

Because glaucoma is a life-long disease, long-term information is important. The AGIS patients will continue to be followed for up to four more years.

AMD and cataract are the leading causes of visual impairment and blindness in the United States. Based on many clinical studies, it is apparent that the frequency of both diseases increases dramatically after age 60. Although excellent treatments for cataract are available, there are no equivalent treatments for AMD. As the average lifespan of our population increases, the number of people who develop AMD will increase dramatically in the years ahead. Unless successful means of prevention or treatment are developed, blindness from AMD -- and its importance as a public health problem -- will increase.

Neither the etiology nor the natural history of AMD or cataract is known. Epidemiologic studies suggest that a number of risk factors may be associated with AMD and cataract, but the strength of the evidence in support of these hypotheses varies. Possibly associated with AMD are personal characteristics, such as age, race, height, family history, and strength of hand grip; ocular characteristics, such as hyperopia and color of iris; and cardiovascular diseases, smoking, lung infections, and chemical exposures. Clinical and laboratory studies suggest the following factors may be associated with progression of AMD: drusen type, choroidal vascular diseases, and photic injury.

Epidemiologic studies of cataract suggest that associated risk factors may include personal characteristics, such as age, sex, race, occupation, and educational status; ocular characteristics, such as iris color; and diabetes mellitus, hypertension, drug exposure, smoking, and sunlight exposure. Animal studies and observational epidemiologic studies suggest that deficiencies in vitamins C and E, carotenoids, and the trace elements zinc and selenium also may be associated with the development of the two diseases, especially cataract. Although surgical treatment to remove cataract is very effective, cataract surgery carries risks, as does any other surgery. Therefore, many research efforts focus on preventing or slowing cataract development, as well as on determining the causes of cataract formation.

The Age-Related Eye Disease Study (AREDS) is a major research program to improve our understanding of the predisposing factors, clinical course, and prognostic factors of AMD and cataract. Eligible patients are randomized to treatment with placebo, antioxidants, zinc, or antioxidants plus zinc, and are followed for a minimum of 5 years.

Men and women between the ages of 55 and 80 years whose macular status ranges from no evidence of AMD in either eye to relatively severe disease with vision loss in one eye but good vision in the fellow eye (20/30 or better) are eligible for the study provided that their ocular media are clear enough to allow good fundus photography.

No longer recruiting. Comments: Completed. Patient recruitment began in September 1990. The first participant was enrolled November 1992, and recruitment ended in July 1995 for all but minority participants. The last participant was enrolled January 1998. A total of 4,757 participants were enrolled.

Completed, with results published. Comments: Ongoing.

AREDS researchers found that people at high risk of developing advanced stages of AMD lowered their risk by about 25 percent when treated with a high-dose combination of vitamin C, vitamin E, beta-carotene, and zinc. In the same high risk group -- which includes people with intermediate AMD, or advanced AMD in one eye but not the other eye -- the nutrients reduced the risk of vision loss caused by advanced AMD by about 19 percent. For those study participants who had either no AMD or early AMD, the supplements did not provide an apparent benefit.

In the cataract portion of the study, researchers discovered that the same nutrients had no significant effect on the development or progression of age-related cataract.

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