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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Makoto Inoue, Kyorin University
ClinicalTrials.gov Identifier:
NCT01658761
First received: July 28, 2012
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Maculopathy
High Myopia
Surgery
Procedure: vitrectomy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes

Further study details as provided by Kyorin University:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Preoperative and postoperative visual acuity


Secondary Outcome Measures:
  • Optical coherence tomography [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Anatomical retinal images by optical cohernce tomography


Enrollment: 64
Study Start Date: September 1998
Study Completion Date: March 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: vitrectomy
Surgery
Other Name: Myopic traction maculopathy in highly myopic eyes

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.

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01658761

Locations
Japan
Kyorin Eye Center
Mitaka, Tokyo, Japan, 181-8611
Sponsors and Collaborators
Kyorin University
Investigators
Principal Investigator: Makoto Inoue, MD Kyorin Eye Center
  More Information

No publications provided

Responsible Party: Makoto Inoue, Assosiate professor of Ophthalmology, Kyorin University
ClinicalTrials.gov Identifier: NCT01658761     History of Changes
Other Study ID Numbers: KyorinEye008, Myopic maculopathy
Study First Received: July 28, 2012
Last Updated: August 1, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyorin University:
Myopic traction maculopathy
vitrectomy
internal limiting membrane
Retrospective, case control study

ClinicalTrials.gov processed this record on September 18, 2014