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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01658761
First Posted: August 7, 2012
Last Update Posted: August 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Makoto Inoue, Kyorin University
  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: Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes

Resource links provided by NLM:


Further study details as provided by Makoto Inoue, Kyorin University:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: One year ]
    Preoperative and postoperative visual acuity


Secondary Outcome Measures:
  • Optical coherence tomography [ Time Frame: One year ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Makoto Inoue, Assosiate professor of Ophthalmology, Kyorin University
ClinicalTrials.gov Identifier: NCT01658761     History of Changes
Other Study ID Numbers: KyorinEye008
Myopic maculopathy
First Submitted: July 28, 2012
First Posted: August 7, 2012
Last Update Posted: August 7, 2012
Last Verified: August 2012

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