Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye

Status Completed

Clinical Trial Summary

The purpose of the study is:

- 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 less than 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.

Clinical Trial Description

Atropine is an effective treatment of moderate amblyopia. Reduction of the plus sphere for the sound eye is an accepted method of enhancing and possibly accelerating the treatment effect. Demonstrating additional value of the plano lens in terms of speed of improvement will shorten the treatment period, possibly improving child and parental compliance, leading to improved overall outcomes for patients with amblyopia. If the plano lens leads to greater improvement, then there will be less permanent visual impairment in patients with a history of amblyopia. It also is important to determine if the use of a plano lens in conjunction with atropine has a deleterious effect on the sound eye, and if yes, how often this occurs.

Little is known about the pharmacologic treatment of severe amblyopia. This study will provide important prospectively determined outcome data at little additional expense.

In a study conducted by the Pediatric Eye Disease Investigator Group, A Randomized Trial Comparing Daily Atropine Versus Weekend Atropine for Moderate Amblyopia, the use of weekend atropine for moderate amblyopia was as effective as daily treatment. Intermittent atropine use (such as using it only on the weekends) has the theoretical potential benefit of the sound eye having some time each week during which cycloplegia is only partial. It is possible that allowing some loss of the cycloplegic effect over the course of each week may be safer for the sound eye.

The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. The two treatment regimes for the 18 week primary treatment period are: 1) Atropine 1% once each weekend day in the sound eye and 2) Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Amblyopia

Clinical Trial Details

NCT number	NCT00315302
Study type	Interventional
Source	Jaeb Center for Health Research
Contact
Status	Completed
Phase	Phase 3
Start date	February 2005
Completion date	January 2008

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04238065` - A Clinical Trial of Caterna Virtual Reality Facilitating Treatment in Children With Amblyopia	N/A
Completed	`NCT04432181` - Comparison of Deviation Types Among Astigmatic Children With Or Without Amblyopia
Terminated	`NCT02767856` - Regimens of Intermittent Occlusion Therapy for Amblyopia in Children	N/A
Completed	`NCT02458846` - Efficacy of Visual Screening in Ontario	N/A
Completed	`NCT01190813` - Levodopa for the Treatment of Residual Amblyopia	Phase 3
Completed	`NCT01109459` - Multimodal Physician Intervention to Detect Amblyopia	N/A
Completed	`NCT04313257` - Monocular Action Video Game Treatment of Amblyopia	N/A
Completed	`NCT04315649` - Effect of 3D Movie Viewing on Stereopsis in Strabismus and / or Anisometropic Amblyops	N/A
Completed	`NCT05223153` - OCT-A and Amblyopia
Recruiting	`NCT05522972` - Establishing New Treatment Approaches for Amblyopia: Perceptual Learning and Video Games	N/A
Completed	`NCT01430247` - Vision Screening for the Detection of Amblyopia	N/A
Completed	`NCT02200211` - Study of Binocular Computer Activities for Treatment of Amblyopia	N/A
Recruiting	`NCT06429280` - Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
Withdrawn	`NCT04959422` - Assuring Ophthalmologic Follow up	N/A
Active, not recruiting	`NCT05612568` - 5 Years of Eye Screening for ARF in Children Aged <3 Years in Flanders
Recruiting	`NCT03655912` - Binocular Visual Therapy and Video Games for Amblyopia Treatment.	N/A
Recruiting	`NCT06150391` - Evaluation of Amblyopia Protocols Using a Dichoptic Gabor Videogame Program	N/A
Completed	`NCT03754153` - Binocularly Balanced Viewing Study	N/A
Withdrawn	`NCT02594358` - Caffeine in Amblyopia Study	Phase 1/Phase 2
Terminated	`NCT02246556` - Dichoptic Virtual Reality Therapy for Amblyopia in Adults	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, 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 marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old — ATS8

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms