Clinical Trial: Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Amblyopia Treatment Study: Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia
Brief Summary:
- To determine whether the success rate with drug treatment (atropine) of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy
- To develop more precise estimates of the success rates of amblyopia treatment
- To identify factors that may be associated with successful treatment of amblyopia
- To collect data on the course of treated amblyopia to provide more precise estimates of treatment effects than are now available
Extended Follow up of Study Patients
- Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years.
- Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care
Detailed Summary:
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
Sponsor: Jaeb Center for Health Research
Current Primary Outcome: Visual acuity in the amblyopic eye [ Time Frame: 6 months ]
Original Primary Outcome:
Current Secondary Outcome:
- Visual acuity in the amblyopic eye [ Time Frame: 24 months ]
- Extended Follow-up: (Primary) To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years [ Time Frame: age 10 years and age 15 years ]
- Extended Follow-up: To determine whether the long-term visual acuity outcome at age 10 yrs and age 15 yrs differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care [ Time Frame: age 10 years and age 15 years ]
Original Secondary Outcome:
Information By: Jaeb Center for Health Research
Dates:
Date Received: September 23, 1999
Date Started: April 1999
Date Completion:
Last Updated: March 5, 2014
Last Verified: March 2014
