Internal Limiting Membrane Flaps for Coexistent Macular Hole and Retinal Detachment

Retinal Detachment Clinical Trial

— ILMFCMHRDPDR  

Official title:

Internal Limiting Membrane Flaps for Coexistent Macular Hole and Retinal Detachment in Eyes of Proliferative Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03618498
• Other study ID #: 180314
• Status: Completed
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: July 15, 2018

Study information

• Verified date: August 2018
• Source: Changhua Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose: To evaluate the logical surgical approaches in closing macular holes in eyes of proliferative diabetic retinopathy with retinal detachment

Description:

High MH closure rate can be achieved. Other than high myopia, MH with RD may appear in several conditions, such as severe vitreomacular traction, proliferative diabetic retinopathy (PDR).clinical charts were reviewed of patients of proliferative diabetic retinopathy suffering from MH with RD who were treated with vitrectomy combined with inverted epiretinal ILM flap,inverted ILM flaps insertion techniques, or free ILM flaps.Standard 3-port 23 or 25 gauged pars plana vitrectomy was performed. After core vitrectomy, anterior-posterior oriented tractions as well as all fibrovascular tissues were removed as thoroughly as possible.The patients were kept in a facedown position overnight and were allowed to take any positions except supine for approximately one week.Various surgical approaches utilizing in managing macular hole may effectively closing macular holes and reattach retina.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 15, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients were proliferative diabetic retinopathy suffering from MH with RD.

Exclusion Criteria:

• Patients were not proliferative diabetic retinopathy suffering from MH with RD.

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment
• Retinal Perforations

Intervention

Procedure:
• ILM flaps insertion techniques or free ILM flaps.
The ILM flap anchoring on the hole edge was inverted and covered the hole.Otherwise, temporal side ILM flap was used. However, if the risk of ILM flipping back was judged to be high, ILM insertion instead of ILM hole coverage was adopted.If the size of the ILM flaps was judged inadequate, the double ILM insertion technique was used, done by adding a piece of previously obtained free ILM flap on top of the inverted ILM tissue until they were securely in place.

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wilcoxon Sign-Rank test	A statistical comparison of average of two dependent samples	Baseline, 12 months.