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WithdrawnNCT02799836Updated Aug 4, 2020

The Effect of Light Deprivation on Visual Functions in Adult Amblyopes

An interventional study of Blindfold in Amblyopia, Anisometropia and Visual Impairment, sponsored by Boston Children's Hospital. Withdrawn. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-08-04.

Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment

Why this study was withdrawn
This study never started, did not receive IRB approval and was closed administratively at the site. Therefore, no subjects were recruited or enrolled.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study summary

Amblyopia is a significant health problem, affecting up to 4% of the population in the United States. Amblyopia, commonly known as "lazy eye," is a developmental visual disorder in which one or both eyes suffer from poor vision as a result of being disadvantaged in early life. Strabismus, or eye misalignment, such as crossed eyes (esotropia) or wandering eyes (exotropia), and anisometropia, or a power difference between the eyes, are the most common causes of amblyopia. If conventional treatment, such as patching the better seeing eye, is not initiated during the critical period of visual development, lasting visual impairment may persist throughout life. This critical period of visual development has been thought to end around age 10. However, recent research has demonstrated that the critical period of visual development can be extended into adulthood. Complete light deprivation in animal models has restored plasticity in the visual cortex and has demonstrated drastic recovery of vision in amblyopic eyes. The objective of this pilot study is to evaluate the impact of complete light deprivation on visual function in a cohort of human adults with severe amblyopia from anisometropia.

02

Conditions studied

  • Amblyopia
  • Anisometropia
  • Visual Impairment
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In context

Amblyopia

183 studies on the registry are indexed under Amblyopia; 43 are open to participants now.

Browse Amblyopia studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Amblyopia, defined as decreased vision, less than or equal to 20/100, in one eye secondary to anisometropia
  • Age 18-50 years

Exclusion criteria

Exclusion Criteria:

  • Strabismus
  • Eye pathology, such as cataract, corneal disorder, maculopathy, glaucoma,
  • Mental health diagnosis, such as depression, schizophrenia, bipolar disorder or anxiety disorder
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Light deprived study subjects

    Study subjects who are blindfolded for 48 hours

    Device: Blindfold

Interventions

  • DeviceBlindfold

    Study subjects will be blindfolded to create an environment of complete light deprivation which will be worn for 48 hours.

06

What researchers measure

Primary outcomes

  1. Logmar visual acuity

    Time frame: Measured at 60 minutes after blindfold is removed

  2. Logmar visual acuity

    Time frame: Measured at one week after blindfold is removed

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — Study subject's visual acuity before and after the intervention will be given to the study subject.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02799836
Lead sponsor
Boston Children's Hospital
Responsible party
Melanie Kazlas (PI, Boston Children's Hospital) — Principal investigator
First posted
Jun 15, 2016
Start date
Aug 1, 2019 (estimated)
Primary completion
Feb 1, 2020 (estimated)
Completion
Jun 1, 2020
Last update
Aug 4, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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