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

NCT02896972 — Not applicable, Completed, 32 participants, Kyorin University

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

Registry	NCT02896972
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: single, treatment
Enrollment	32 (Actual)
Sponsor	Kyorin University (Other)
Conditions	Macular Hole Retinal Detachment
Interventions	Vitrectomy (Procedure)
Dates	start 2012-04-01, primary completion 2016-03-01, completion 2016-09-01, first posted 2016-09-12, last updated 2017-01-10

-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)

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+Detailed 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.

+Arms and interventions

Arm	Type	Interventions	Description
Inverted ILM flap group	Active comparator	Procedure: Vitrectomy	Eyes underwent vitrectomy with inverted internal limiting membrane technique
ILM peeling group	Active comparator	Procedure: Vitrectomy	Eyes underwent vitrectomy with internal limiting membrane peeling

Vitrectomy (Procedure): Vitrectomy with inverted ILM technique or ILM peeling

+Outcome measures

Primary outcomes

Visual acuity before and after surgery [Changes from baseline to 1, 3, 6 months]

Secondary outcomes

Optical coherence tomography [Changes from baseline up to 6 months]

+Eligibility

Sex: All, ages: 20 Years to 90 Years

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.

+Investigators

Makoto Inoue, MD, Principal investigator, Kyorin Eye Center