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Current Studies |
Active-Recruiting Studies
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Correction of Refractive Error for Amblyopia Protocol
Objectives:
The Pediatric Eye Disease Investigator Group (PEDIG) is conducting a series of clinical trials of children with amblyopia. Prior to enrollment into one of the trials, it is necessary for the child’s refractive error to be corrected with spectacles. The purpose of this protocol is to provide the requisite spectacles when refractive error has not already been appropriately corrected and then to follow the child according to the investigator’s usual routine until visual acuity is stable. At that time, if amblyopia is still present, the child’s eligibility for an amblyopia treatment protocol will be assessed.
A Randomized Trial of Full-time Bangerter Filters versus Part-time Daily Patching for the Treatment of Moderate Amblyopia in Children
Objectives:
A Randomized Trial to Evaluate 8 Hours of Daily Patching Plus Daily Atropine for Residual Amblyopia in Children 3 to <8 Years Old
Objectives:
This study is designed to evaluate the effectiveness of treatment of residual amblyopia in children ages 3 to <8 years with visual acuity of 20/32 to 20/50 in the amblyopic eye. The study is a randomized clinical trial comparing intensive treatment (8 hours of daily patching plus daily atropine) with a control group that will have rapid weaning of existing treatment followed by spectacle correction only (if needed). The primary objective is to determine if intensive treatment will improve visual acuity in patients with residual amblyopia.
Enrollment Completed
- Follow Up Active
A Randomized Trial to Compare Near Versus Distance Activities While Patching for Amblyopia
A Randomized Trial Comparing Patching versus Atropine for Amblyopia in 7 to <13 Year Olds
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Long Term Follow Up of Amblyopia Treatment
Recruitment of the Occlusion versus Pharmacologic Therapy for Moderate Amblyopia study began in April 1999 and closed in April 2001 after 419 patients were enrolled. Six-month follow-up (primary outcome exam) was completed in November 2001. Two year follow up of patients was completed in July 2003. For more information click here: Occlusion versus Pharmacologic Therapy for Moderate Amblyopia
Extended follow up of study patients is ongoing.
Objective of Extended Follow up of Study Patients
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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.
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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
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An Observational Study of Infantile, Acquired Non-accommodative, and Acquired Partially-accommodative Esotropia
Objectives:
Randomized Trial to Compare Near Versus Distance Activities While Patching for Amblyopia
Objective:
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A Randomized Trial Comparing Atropine to Atropine
Plus a Reduced-Plus Lens for the Sound Eye as Treatments for Amblyopia
in Children 3 to <7 Years Old
Objectives:
- To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to <7 years old.
- To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine treatment with and without a plano lens.
A Randomized Trial Comparing Patching versus Atropine
for Amblyopia in 7 to <13 Year Olds
Objectives:
- To compare the effectiveness of weekend atropine plus near
activities and daily patching plus near activities for moderate amblyopia
(20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in 7 to <13
years olds.
- To determine the maximum improvement with each treatment.
A Study of Retinal Nerve Fiber Layer
Thickness in Amblyopia
Objectives:
• To determine whether amblyopia is associated with structural abnormalities of optic nerve fiber layer.
A Prospective Study of Primary
Surgical Treatment of Nasolacrimal Duct Obstruction in Children Less
Than Four Years Old
Objective:
- The primary objective of the study is to report the success proportions of simple probing within different age groups of patients under 2 years of age. Secondary objectives are to obtain descriptive data regarding symptoms and quality of life in patients receiving simple probing.
A Prospective Study of Surgical Procedures for
the Treatment of Persistent Nasolacrimal Duct Obstruction in Children
less than Four Years Old
Objectives:
- The primary objective of the study is to report the success proportions for the treatment of persistent nasolacrimal duct obstruction for three surgical procedures: balloon catheter dilation, nasolacrimal intubation, and simple probing.
- Secondary objectives are to obtain descriptive data regarding
symptoms and quality of life in patients receiving each type of surgical
procedure, and to compare success proportions between patients undergoing
balloon catheter dilation and those undergoing nasolacrimal intubation.
A Randomized Trial of the Effect of Progressive Addition Lenses
Versus Single Vision Lenses on Low Myopia Associated with Large Accommodative
Lags and Near Esophoria in Children
Objective:
- The principal objective of this randomized trial is to determine if progressive addition lenses (PALs) versus single vision lenses (SVLs) slow the progression of low myopia in children with poor accommodative responses (i.e., large accommodative lags) and near esophoria.