Inverted Internal Limiting Membrane Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes

Macular Hole Retinal Detachment Clinical Trial

Official title:

Efficacy of Inverted Internal Limiting Membrane Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896972
• Other study ID #: Kyorineye022
• Status: Completed
• Phase: N/A
• First received: September 7, 2016
• Last updated: January 9, 2017
• Start date: April 2012
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: Kyorin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap technique for macular hole retinal detachment (MHRD) in highly myopic eyes, and to demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using swept-source optical coherence tomography (OCT)

Description:

Macular hole retinal detachment (MHRD) threatens a certain number of highly myopic patients for irreversible visual dysfunction, and mostly requires immediate surgical intervention. The aim of they study is to evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap technique for MHRD in highly myopic eyes, and to demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using swept-source optical coherence tomography.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• The inclusion criteria were patients who underwent vitrectomy and internal limiting membrane removal or inverted for macular hole retinal detachment and had followed for more than 6 months.

Exclusion Criteria:

• The patients with follow-up less than 6 months.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dissociative Disorders
• Macular Hole Retinal Detachment
• Retinal Detachment
• Retinal Perforations

Intervention

Procedure:
• Vitrectomy
Vitrectomy with inverted ILM technique or ILM peeling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyorin University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity before and after surgery		Changes from baseline to 1, 3, 6 months	No
Secondary	Optical coherence tomography		Changes from baseline up to 6 months	No