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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02528045
Other study ID # Kyorineye017
Secondary ID
Status Completed
Phase N/A
First received August 16, 2015
Last updated August 18, 2015
Start date June 2012
Est. completion date June 2015

Study information

Verified date August 2015
Source Kyorin University
Contact n/a
Is FDA regulated No
Health authority Institutional review board: Japan
Study type Observational

Clinical Trial Summary

The medical records of 16 eyes of 16 patients with macular hole retinal detachment or myopic traction maculopathy who received viterctomy including internal limiting membrane peeling and scleral shorting surgery were reviewed. Best-corrected visual acuity, axial length, retinal reattachment and macular hole closure, the shape of staphyloma determined by optical coherence tomography and 3-dimensional magnetic resonance imaging were assessed.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date June 2015
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria:

- The inclusion criteria were patients who had highly myopic eyes with macular hole retinal detachment to myopic traction maculopathy

Exclusion Criteria:

- The patients with follow-up less than 6 months

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Intervention

Procedure:
Vitrectomy with scleral shortening


Locations

Country Name City State
Japan Makoto Inoue 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 before and after surgery Comparison with logarithm of Minimum Angle of Resolution (logMAR) vision 6 months Yes
Secondary Retinal reattachment Retinal reattachment or resolution of myopic traction maculopathy 6 months Yes
See also
  Status Clinical Trial Phase
Completed NCT02528058 - Ultrastructure Analysis of Excised Internal Limiting Membrane in Eyes of Highly Myopia With Myopic Traction Maculopathy N/A
Completed NCT04278079 - Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy N/A