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

NCT ID: NCT02010138

Last Updated: 2016-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-11-30

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.

Conditions

Macular Holes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Small Extent Group (SG)

Patients who were scheduled for surgery for idiopathic macular hole were randomly assigned to the SG. The small-extent peeling was performed in SG.

Group Type: ACTIVE_COMPARATOR

small-extent peeling

Intervention Type: PROCEDURE

The internal limiting membrane was peeled in round shape with the radius of 0.75-disc diameter radius (1.5-disc diameter in total) centering at the center of the macular hole.

Large Extent Group (LG)

Patients who were scheduled for surgery for idiopathic macular hole were randomly assigned to the LG. The large-extent peeling was performed in LG.

Group Type: ACTIVE_COMPARATOR

large-extent peeling

Intervention Type: PROCEDURE

The internal limiting membrane was peeled in round shape with the radius of 1.5-disc diameter radius (3.0-disc diameter in total) centering at the center of the macular hole.

Interventions

small-extent peeling

The internal limiting membrane was peeled in round shape with the radius of 0.75-disc diameter radius (1.5-disc diameter in total) centering at the center of the macular hole.

Intervention Type: PROCEDURE

large-extent peeling

The internal limiting membrane was peeled in round shape with the radius of 1.5-disc diameter radius (3.0-disc diameter in total) centering at the center of the macular hole.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• idiopathic macular hole

Exclusion Criteria

• macular hole associated with other causative diseases

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kunho Bae, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

Locations

Samsung Medical Center

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

2013-07-083

Identifier Type: -

Identifier Source: org_study_id