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ILM Inverted Flap Size in Macular Hole

Primary Purpose

Idiopathic Macular Hole

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pars plana vitrectomy with ILM inverted flap
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Macular Hole

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eyes with stage 4 idiopathic MHs with a diameter >250µm on spectral domain optical coherence tomography (SD-OCT)

Exclusion Criteria:

  • traumatic MH
  • myopic MHs,
  • MH secondary to retinal detachment,
  • long-standing MH> 12 months
  • previous retinal surgeries
  • high myopia with an axial length > 26.0 mm
  • other ocular pathologies interfering with the interpretation of the OCT reports.

Sites / Locations

  • Ophthalmic center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

small flap medium-sized macular hole (SFMM)

large flap medium-sized macular hole (LFMM)

small flap large-sized macular hole (SFLM)

large flap Large-sized macular hole (LFLM)

Arm Description

small flap (1-2 disc-diameter) was performed in medium sized macular hole (250-400 um)

large flap (3-4 disc-diameter) was performed in medium sized macular hole (250-400 um)

small flap (1-2 disc-diameter) was performed in Large sized macular hole (>400 um)

large flap (3-4 disc-diameter) was performed in large sized macular hole (>400 um)

Outcomes

Primary Outcome Measures

rate of macular hole closure
defined as the proportion of the eyes with complete MH closure based on SD-OCT findings

Secondary Outcome Measures

timing of MH closure
the time of complete macular hole closure
BCVA
best corrected visual acuity

Full Information

First Posted
December 19, 2020
Last Updated
December 24, 2020
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04683276
Brief Title
ILM Inverted Flap Size in Macular Hole
Official Title
Impact of the Inverted Internal Limiting Membrane Flap Diameter on Idiopathic Macular Hole Closure: Comparative Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In the current study, the investigators described the results of a randomized, comparative clinical trial that was conducted to study the impact of the size of internal limiting membrane (ILM) inverted flap on rate and timing of idiopathic macular hole closure.
Detailed Description
A prospective randomized comparative study included patients with idiopathic macular hole (MH) attending outpatient clinic.Eligible eyes were divided into 2 groups based on the narrowest diameter of the MH measured by spectral domain optical coherence tomography (SD-OCT). MHs from 250 to 400µm were classified as Medium-sized MHs and MHs > 400 µm were classified as Large-sized MHs. Within each group, eyes were randomly assigned to either small-flap (1-2DD) or large flap (from >2 to 4DD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Macular Hole

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
small flap medium-sized macular hole (SFMM)
Arm Type
Active Comparator
Arm Description
small flap (1-2 disc-diameter) was performed in medium sized macular hole (250-400 um)
Arm Title
large flap medium-sized macular hole (LFMM)
Arm Type
Active Comparator
Arm Description
large flap (3-4 disc-diameter) was performed in medium sized macular hole (250-400 um)
Arm Title
small flap large-sized macular hole (SFLM)
Arm Type
Active Comparator
Arm Description
small flap (1-2 disc-diameter) was performed in Large sized macular hole (>400 um)
Arm Title
large flap Large-sized macular hole (LFLM)
Arm Type
Active Comparator
Arm Description
large flap (3-4 disc-diameter) was performed in large sized macular hole (>400 um)
Intervention Type
Procedure
Intervention Name(s)
pars plana vitrectomy with ILM inverted flap
Intervention Description
Complete vitrectomy was done with the aid of triamcinolone acetonide followed by fluid-air exchange. Staining of the ILM was carried with 0.05% solution of Brilliant Blue dye (BBG), (Ocublue plus, Aurolab, India) for 30 seconds, ILM peeling was proceeded leaving a circle of ILM measuring approximately 1-2 DD in SF groups and >2 to 4DD in LF group, centered around the MH. The ILM outside the parafoveal area was peeled to the arcade. The ILM around the hole was then detached from the retina up to the edge of the hole. The ILM flap around the edge of the hole was inverted over the MH using a scraper.
Primary Outcome Measure Information:
Title
rate of macular hole closure
Description
defined as the proportion of the eyes with complete MH closure based on SD-OCT findings
Time Frame
6 months
Secondary Outcome Measure Information:
Title
timing of MH closure
Description
the time of complete macular hole closure
Time Frame
6 months
Title
BCVA
Description
best corrected visual acuity
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eyes with stage 4 idiopathic MHs with a diameter >250µm on spectral domain optical coherence tomography (SD-OCT) Exclusion Criteria: traumatic MH myopic MHs, MH secondary to retinal detachment, long-standing MH> 12 months previous retinal surgeries high myopia with an axial length > 26.0 mm other ocular pathologies interfering with the interpretation of the OCT reports.
Facility Information:
Facility Name
Ophthalmic center
City
Mansoura
State/Province
Dakahelia
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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ILM Inverted Flap Size in Macular Hole

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