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NCT01658761 Clinical Trial

Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes

Surgery Clinical Trial

Official title:
Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01658761
Other study ID # KyorinEye008
Secondary ID Myopic maculopat
Status Completed
Phase N/A
First received July 28, 2012
Last updated August 1, 2012
Start date September 1998
Est. completion date March 2012

Study information
Verified date August 2012
Source Kyorin University
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date March 2012
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 90 Years
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• vitrectomy
Surgery

Locations
Country Name City State
Japan Kyorin Eye Center Mitaka Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Kyorin University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual acuity Preoperative and postoperative visual acuity One year Yes
Secondary Optical coherence tomography Anatomical retinal images by optical cohernce tomography One year Yes
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