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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03174639
• Collaborator: (none)
• Enrollment: 8
• Arm: 1
• Actual Duration (Months): 3.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
High Myopia; Macular Holes; Retinal Detachment	Procedure: Inverted and free ILM insertion	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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)
• Actual Study Start Date: Mar 11, 2016
• Actual Primary Completion Date: Jun 30, 2016
• Actual Study Completion Date: Jun 30, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Closure of macular hole [3 months]

   Closure of macular hole demonstrated by optical coherence tomography

Secondary Outcome Measures

1. Retinal reattachment [3 months]

   Retinal reattachment observed by fundoscopy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Macular hole with retinal detachment in high myopia

Exclusion Criteria:

• History of trauma, peripheral retinal breaks

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT03174639
• Other Study ID Numbers: 201512113RINA
• First Posted: Jun 2, 2017
• Last Update Posted: Jun 2, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myopia; Retinal Detachment; Retinal Perforations; Dissociative Disorders

Study Results

No Results Posted as of Jun 2, 2017