Extent of ILM Removal and Its Impact on Outcomes of MH Surgery

Not Applicable

Completed

• Conditions: Macular Holes
• Interventions: Procedure: large-extent peeling; Procedure: small-extent peeling

• Registration Number: NCT02010138
• Lead Sponsor: Samsung Medical Center

Brief Summary

Eligible patients who were scheduled for surgery for idiopathic macular hole (MH) were equally randomized to small extent group or large extent group depending on the extent of internal limiting membrane (ILM) to be removed. The ILM was peeled in round shape with the radius of either 0.75-disc diameter or 1.5-disc diameter according to the group. The primary analysis was conducted to identify the difference of functional and anatomical outcomes between the two groups. Subsequent analysis was performed to reveal the relationship between the functional and anatomical outcomes.

Detailed Description

This randomized clinical trial was performed at a single center. Patients who were scheduled for surgery for idiopathic macular hole (MH) were enrolled. Eligible patients were equally randomized to small extent group or large extent group depending on the extent of ILM to be removed. Random numbers were generated through computerized block-randomization.

A standard 3-port pars plana vitrectomy was performed by a single surgeon using 23-gauge vitrectomy system, with a 1-step scleral tunnel incision. After posterior vitreous detachment was achieved, peeling of the ILM was performed by an end gripping forceps with the assistance of indocyanine green dye. The ILM was peeled in round shape with the radius of either 0.75-disc diameter or 1.5-disc diameter centering at the center of the MH according to the pre-assigned group. This was followed by a complete fluid-gas exchange, and all patients were encouraged to maintain a face-down position for at least 5 days postoperatively.

Postoperative measurements of BCVA and M-score were conducted at 2- and 6-month follow-up visits by independent masked observers. The first postoperative SD-OCT scanning was usually conducted at 1 to 2 weeks after operation according to the intraocular gas status. Then, OCT scans were conducted at follow-up visits 2, and 6 months postoperatively. The same experienced examiner conducted all the OCT scans on all subjects.

Comparison of anatomical closure, BCVA, M-score, Δ BCVA, and Δ M-score were primarily performed between the two groups. Then, the parameters measured from OCT scans with changes in ETDRS visual acuity and M-score were analyzed.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-12
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• idiopathic macular hole

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Exclusion Criteria

• macular hole associated with other causative diseases

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Large Extent Group (LG)	large-extent peeling	Patients who were scheduled for surgery for idiopathic macular hole were randomly assigned to the LG. The large-extent peeling was performed in LG.
Small Extent Group (SG)	small-extent peeling	Patients who were scheduled for surgery for idiopathic macular hole were randomly assigned to the SG. The small-extent peeling was performed in SG.

Primary Outcome Measures

Name	Time	Method
Degree of foveal elongation	postoperative 6months

Secondary Outcome Measures

Name	Time	Method
metamorphopsia	6months

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of