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

NCT02010138 | Completed

• 1 other identifier: 2013-07-083
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Holes

Keywords

Internal Limiting Membrane; Metamorphopsia

Outcome Measures

Primary Outcomes (1)

• Degree of foveal elongation

  postoperative 6months

Secondary Outcomes (1)

• metamorphopsia

  6months

Other Outcomes (1)

• change in visual acuity

  6 months

Study Arms (2)

Small Extent Group (SG)

ACTIVE COMPARATOR

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

Procedure: small-extent peeling

Large Extent Group (LG)

ACTIVE COMPARATOR

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

Procedure: large-extent peeling

Interventions

small-extent peeling 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.

Small Extent Group (SG)

large-extent peeling 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.

Large Extent Group (LG)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• idiopathic macular hole

You may not qualify if:

• macular hole associated with other causative diseases

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 06315, South Korea

Location

MeSH Terms

Conditions

Retinal Perforations; Vision Disorders

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kunho Bae, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 12, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 7, 2016

Record last verified: 2016-01

Locations

KR (1)