Internal Limiting Membrane Flaps for Coexistent Macular Hole and Retinal Detachment

NCT03618498 | Completed DMC

• 1 other identifier: 180314
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retinal Detachment

Keywords

macular hole; retinal detachment; PDR

Outcome Measures

Primary Outcomes (1)

• Wilcoxon Sign-Rank test

  A statistical comparison of average of two dependent samples

  Baseline, 12 months.

Study Arms (1)

Patient accept surgery

OTHER

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.

Procedure: ILM flaps insertion techniques or free ILM flaps.

Interventions

ILM flaps insertion techniques or free ILM flaps. PROCEDURE

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.

Patient accept surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

Changhua Christian Hospital

Changhua, Taiwan

Location

MeSH Terms

Conditions

Retinal Detachment; Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Chen San-Ni, MD

  Changhua Christian Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Model Details: A 25-gauged blunt-tipped needle connected with Viscoat® (Alcon laboratories, Fort Worth, TX, USA) containing syringe was placed within the macular hole just below the level of the macular hole. A small amount of Viscoat® was injected into and around the hole. An ICG solution (25 mg ICG in 15 ml 5% glucose-water solution, final concentration = 1.7 mg/ml) was then carefully applied around the macular hole within the arcade.Excessive ICG was immediately removed by suction. ILM at the parafoveal area was peeled in a circular fashion. Care was taken not to peel the ILM flap across the hole edge. If possible, at least 1.5 to 2 disc area of partially detached ILM around the hole was left in place with central part remained attached to the edge of the hole.

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 7, 2018
• Study Start: March 7, 2018
• Primary Completion: May 31, 2018
• Study Completion: July 15, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

TW (1)