High Myopia Macular Hole and Retinal Detachment Treated With Double ILM Flaps

High Myopia Macular Hole and Retinal Detachment Accepted Internal Limiting Membrane Flip Packing and Free Flap Was the Internal Limiting Membrane (ILM Flap Was Double)

From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ILM flap insertion into the hole were retrospectively reviewed. The anatomical and function outcomes were assessed.

Study Overview

• Status: Completed
• Conditions: Retinal Detachment; High Myopia; Macular Holes
• Intervention / Treatment: Procedure: Inverted and free ILM insertion

Detailed Description

From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ILM flap insertion into the hole were retrospectively reviewed. The anatomical and function outcomes were assessed. Patients with a history of trauma or concurrent peripheral breaks were excluded. The anatomical and function outcomes, including the status of the macular hole and retina were assessed.The study was approved by the ethnic committee and research board.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Macular hole with retinal detachment in high myopia

Exclusion Criteria:

• History of trauma, peripheral retinal breaks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inverted and free ILM insertion; Both inverted and free ILM flaps were inserted into the macular hole	Procedure: Inverted and free ILM insertion; ILM was peeled and the ILM flap was inverted and inserted into the macular hole, followed by insertion of free ILM flap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Closure of macular hole	Closure of macular hole demonstrated by optical coherence tomography	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal reattachment	Retinal reattachment observed by fundoscopy	3 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Publications and helpful links

General Publications

• Chen SN, Yang CM. Double Internal Limiting Membrane Insertion for Macular Hole-Associated Retinal Detachment. J Ophthalmol. 2017;2017:3236516. doi: 10.1155/2017/3236516. Epub 2017 Jul 30.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2016
• Primary Completion (Actual): June 30, 2016
• Study Completion (Actual): June 30, 2016

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): June 2, 2017
• Last Update Submitted That Met QC Criteria: May 31, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Eye Diseases; Retinal Diseases; Refractive Errors; Myopia; Retinal Perforations; Retinal Detachment; Dissociative Disorders
• Other Study ID Numbers: 201512113RINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No