Ultrastructure Analysis of Excised Internal Limiting Membrane in Eyes of Highly Myopia With Myopic Traction Maculopathy

Myopic Traction Maculopathy Clinical Trial

Official title:

Ultrastructure Analysis of Excised Internal Limiting Membrane in Eyes of Highly Myopia With Myopic Traction Maculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528058
• Other study ID #: Kyorineye018
• Status: Completed
• Phase: N/A
• First received: August 16, 2015
• Last updated: August 17, 2015
• Start date: June 2010
• Est. completion date: July 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 excised ILM from 7 eyes of 7 patients with MTM including 7 eyes with macular retinoschisis and 4 eyes with foveal detachment but without any retinal break underwent vitrectomy with induction of posterior vitreous detachment and ILM peeling was examined to evaluate ultrastructure with electron microscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 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 underwent vitrectomy and internal limiting membrane peeling for myopic traction maculopathy and had a follow-up for more than 6 months.

Exclusion Criteria:

• The patients with follow-up less than 6 months

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Myopia
• Myopic Traction Maculopathy

Intervention

Procedure:
• Vitrectomy with internal limiting membrane peeling

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 in logarithm of Minimum Angle of Resolution (logMAR) vision	6 months	Yes
Secondary	Retinal reattachment	Resolution of macular retinoschisis and foveal detachment	6 months	Yes