- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01658761
Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes
August 1, 2012 updated by: Makoto Inoue, Kyorin University
Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was evaluated in each stage.
Efficacy of internal limiting membrane was also evaluated whether it may improve visual outcome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was evaluated in each stage of macular retinischisis, foveal detachment, or macular hole.
Efficacy of internal limiting membrane was also evaluated whether it may improve visual outcome.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tokyo
-
Mitaka, Tokyo, Japan, 181-8611
- Kyorin Eye Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Eyes with myopic traction maculopathy in highly myopic eyes with refractive errors ≤ -8.0 diopters and axial length ≥ 26.0 mm who underwent vitrectomy
Exclusion Criteria:
- Eyes with follow-up less than a year
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Myopic traction maculopathy
The 71 eyes of 64 patients (14 men and 50 women) with myopic traction maculopathy in highly myopic eyes (refractive errors ≤-8.0 diopters and axial length ≥26.0 mm) who underwent vitrectomy were retrospectively reviewed.
|
Surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual acuity
Time Frame: One year
|
Preoperative and postoperative visual acuity
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optical coherence tomography
Time Frame: One year
|
Anatomical retinal images by optical cohernce tomography
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1998
Primary Completion (ACTUAL)
February 1, 2011
Study Completion (ACTUAL)
March 1, 2012
Study Registration Dates
First Submitted
July 28, 2012
First Submitted That Met QC Criteria
August 1, 2012
First Posted (ESTIMATE)
August 7, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
August 7, 2012
Last Update Submitted That Met QC Criteria
August 1, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KyorinEye008
- Myopic maculopathy
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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