MedDataX Logo

Effectiveness of Telescopic Magnification in the Treatment of Amblyopia

NCT ID: NCT00970554

Last Updated: 2013-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Amblyopia is a visual impairment of one eye that results from disuse of that eye during early brain development. The standard treatment for amblyopia consists of patching or pharmacological penalization of the sound eye. Unfortunately, approximately 50% of amblyopic children do not respond to these therapies, with poor compliance being a major factor in treatment failure. One new treatment strategy involves patching the sound eye while using a telescopic device on the amblyopic eye to magnify the images formed in the amblyopic eye. Children were randomized to receive either daily patching of the sound eye for 30 minutes only (patching only group), or daily patching of the sound eye for 30 minutes plus simultaneous use of a telescopic device by the amblyopic eye during patching (patching plus telescope group).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The goal of the present investigation was to conduct a prospective randomized clinical study to further evaluate the effectiveness of telescopic magnification plus patching vs patching alone on different types of amblyopia in patients who had failed previous treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Amblyopia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Amblyopia Telescopic magnification Patching

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patching only

Group Type ACTIVE_COMPARATOR

Patching

Intervention Type OTHER

Patching of the sound eye for 30 minutes a day for 17 weeks.

Patching plus telescope group

Group Type EXPERIMENTAL

Telescopic magnification

Intervention Type OTHER

Patching of the sound eye plus simultaneous use of a telescopic device by the amblyopic eye for 30 minutes a day for 17 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Patching

Patching of the sound eye for 30 minutes a day for 17 weeks.

Intervention Type OTHER

Telescopic magnification

Patching of the sound eye plus simultaneous use of a telescopic device by the amblyopic eye for 30 minutes a day for 17 weeks.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aged 4-17 years
* Strabismic, refractive (anisometropic), isometropic or mixed mechanism amblyopia

* Strabismic amblyopia is defined as amblyopia (1) in the presence of either an inability to maintain parallel visual axes (heterotropia) at distance or near fixation or both, or a history of strabismus surgery (or botulinum injection), and (2) in the absence of refractive error meeting the criteria below for mixed mechanism amblyopia
* Refractive/Anisometropic amblyopia is defined as amblyopia in the presence of a difference in refractive error between the two eyes (anisometropia) of ≥0.5 diopter (D) of spherical equivalent or ≥1.5D of difference in astigmatism in any meridian, with no measurable heterophoria at distance or near fixation, which persisted after 12 weeks of spectacle correction
* Isometropic amblyopia is defined as amblyopia in the presence a refractive error ≥5.0D of spherical equivalent in both eyes, but not meeting the criteria of anisometropic amblyopia
* Mixed mechanism strabismic and refractive amblyopia is defined as the presence of both strabismic and anisometropic types of amblyopia
* Ability to read the ETDRS letter chart
* Visual acuity between 0.3 and 1.3 logMAR (i.e., between 20/40 and 20/400) in the amblyopic eye
* Visual acuity of 0.3 logMAR (i.e., 20/40) or better in the sound eye
* Interocular acuity difference ≥0.3 logMAR
* Appropriate refractive error correction for at least 12 weeks

Exclusion Criteria

* Presence of an ocular cause of reduced visual acuity
* Myopia with a spherical equivalent of -6.0D or more, due to the likely presence of pathological myopia
* Prior intraocular surgery
* Known skin reaction to patch or bandage adhesive
Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Agnes Wong

Ophthamologist-In-Chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Agnes Wong, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto, Canada

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

Wu J, Nazemi F, Schofield J, Mirabella G, Wong AM. Effectiveness of telescopic magnification in the treatment of amblyopia: a pilot study. Arch Ophthalmol. 2010 Mar;128(3):297-302. doi: 10.1001/archophthalmol.2009.400.

Reference Type DERIVED
PMID: 20212198 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1000011712

Identifier Type: -

Identifier Source: org_study_id