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Binocular Treatment of Amblyopia Before and After Strabismus Surgery

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ClinicalTrials.gov Identifier: NCT01791946
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary

Tracking Information
First Submitted Date  ICMJE February 7, 2013
First Posted Date  ICMJE February 15, 2013
Last Update Posted Date January 13, 2017
Study Start Date  ICMJE January 2013
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2013)
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, 7 weeks, and 3 months. ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Binocular Treatment of Amblyopia Before and After Strabismus Surgery
Official Title  ICMJE Binocular Treatment of Amblyopia Before and After Strabismus Surgery
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Amblyopia
  • Strabismus
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Binocular Treatment
  • 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.
    Intervention: Procedure: Binocular Treatment
  • 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.
    Intervention: Procedure: Sham Binocular Treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2013)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01791946
Other Study ID Numbers  ICMJE 12-186H
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: We do not [plan on sharing IPD with other researchers.
Responsible Party Massachusetts Eye and Ear Infirmary
Study Sponsor  ICMJE Massachusetts Eye and Ear Infirmary
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dean Cestari, M.D. Massachusetts Eye and Ear Infirmary
PRS Account Massachusetts Eye and Ear Infirmary
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP