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Binocular Treatment of Amblyopia Before and After Strabismus Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01791946
First received: February 7, 2013
Last updated: January 12, 2017
Last verified: October 2015
  Purpose
The primary objective of this study is to assess the effectiveness of an investigational binocular treatment in improving vision in strabismic amblyopes (i.e., patients with lazy eye, or poor vision in one eye due to a present or former eye misalignment). Patients will be randomized to receive the study treatment either before or after strabismus surgery (i.e., corrective eye alignment surgery) or sham treatment before surgery. The study hypothesis is that there will be no significant change in vision in neither the pre nor post-surgery groups and no significant change in vision in neither the sham nor actual treatment groups.

Condition Intervention
Amblyopia
Strabismus
Procedure: Binocular Treatment
Procedure: Sham Binocular Treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Binocular Treatment of Amblyopia Before and After Strabismus Surgery

Resource links provided by NLM:


Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • The primary outcome variable is a composite of the difference in visual acuity and stereo vision measurements taken before binocular treatment and strabismus surgery versus after binocular treatment and strabismus surgery. [ Time Frame: This is a change outcome measure. That is measurements will be taken at baseline, 6 weeks, and approximately 3 months. ]

Enrollment: 22
Study Start Date: January 2013
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group A (Post-Surgery)
Subjects enrolled in this arm will first have eye alignment corrective surgery and then complete six weeks of the investigational binocular treatment training.
Procedure: Binocular Treatment
The binocular treatment involves the completion of visual tasks via virtual reality goggles. The stimulus is presented to each eye separately, allowing for varying levels of contrast to be presented to each eye. (The visual task is therefore made more or less difficult with the variation of contrast presented to either eye.) Subjects will complete the computer-based visual tasks for approximately 36 hours total over the course of six weeks, or six hours per week for six weeks.
Experimental: Treatment Group B (Pre-Surgery)
Subjects enrolled in this arm will first complete six weeks of the investigational binocular treatment training and then have eye alignment corrective surgery.
Procedure: Binocular Treatment
The binocular treatment involves the completion of visual tasks via virtual reality goggles. The stimulus is presented to each eye separately, allowing for varying levels of contrast to be presented to each eye. (The visual task is therefore made more or less difficult with the variation of contrast presented to either eye.) Subjects will complete the computer-based visual tasks for approximately 36 hours total over the course of six weeks, or six hours per week for six weeks.
Sham Comparator: Sham Treatment
Subjects enrolled in this arm will first complete six weeks of the sham binocular treatment and then undergo eye alignment corrective surgery.
Procedure: Sham Binocular Treatment
The sham treatment involves the same computer-based visual tasks and timeframe as the binocular treatment training but there will be no variation in contrast presentation to either eye.

Detailed Description:

This is a placebo-controlled, partially-randomized clinical trial. The patients will be assigned to one of two groups, Treatment Group A or Treatment B group. To help minimize bias, a blinded staff member will perform the visual acuity assessments throughout the study. The PI and Sub-I's will remain blinded to the treatment groups so that they may perform the visual exams throughout the study, if necessary.

Patients who have had strabismus surgery prior to being recruited will be allowed to participate in the study and, if eligible, will be automatically assigned to Treatment Group A.

Patients who are scheduled to have strabismus surgery at least six weeks from their screening clinic visit will be allowed to participate, once eligibility is determined. These patients will be included in Treatment Group B and randomized to either actual treatment or sham treatment. Each eligible participant will be included in the study and blinded as to which treatment group s/he has been assigned.

The duration of each subject's participation in the study will be about 7.5 months. All subjects will have a baseline visit to assess eligibility. Subjects in Treatment Group A will undergo strabismus surgery, if it was not previously performed, followed by 6 weeks of binocular treatment and a 3-6 month follow-up period. NOTE: There will be 4-6 weeks between surgery and the start of treatment to allow for full post-surgery recovery before starting treatment. Subjects in Treatment Group B will undergo 6 weeks of treatment/sham followed by strabismus surgery and a 3-6 month follow-up period.

If a treatment effect on vision is found, participants enrolled in the sham treatment arm will be offered the binocular treatment at the conclusion of the study and following surgery. Sham participants will be allowed to receive the study treatment so long as they have completed the study and there is no presence of any new medical condition following surgery that would be considered reasons for exclusion by the treating physician.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of amblyopia in one eye due to congenital strabismus.
  • Amblyopic eye has a fully-corrected visual acuity of 20/30 or less with no other cause for the visual loss except amblyopia.
  • Patient is 18 to 60 years old.
  • Corrected vision in other eye is normal.
  • Eligible for strabismus surgery or has completed it previously with a successful outcome, as determined by the treating physician.
  • Available and willing to comply with examination procedures and schedule.
  • Signed and dated informed consent.

Exclusion Criteria:

  • Fully-corrected visual acuity of less than 20/30 in both eyes.
  • Visual decrement due to anything other than amblyopia.
  • At high risk for developing intractable diplopia (double vision) if vision in weak eye is improved. (To be determined by treating physician.)
  • Unable or unavailable to complete at least 18 hours of binocular treatment over the course of six weeks.
  • Currently enrolled in another research study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01791946

Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Dean Cestari, M.D. Massachusetts Eye and Ear Infirmary
  More Information

Publications:
Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01791946     History of Changes
Other Study ID Numbers: 12-186H
Study First Received: February 7, 2013
Last Updated: January 12, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: We do not [plan on sharing IPD with other researchers.

Keywords provided by Massachusetts Eye and Ear Infirmary:
lazy eye
cross eye
cross eyed

Additional relevant MeSH terms:
Amblyopia
Strabismus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Ocular Motility Disorders
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on May 25, 2017