NCT00190190

Brief Summary

Rational of the study: for macular holes larger than 400 µm the rate of failure is of more than 20%. It is for these eyes that it is necessary to show the benefit of internal limiting membrane (ILM) peeling in term of vision and success rate. In order to test the benefit of this gesture, it is necessary to make a randomized study. Primary objective: To show that the percentage of success (anatomical closing, confirmed by OCT) at third postoperative month is higher in the ILM peeling group. Design of the study: Randomized multicentric study, in parallel groups, with individual benefit for the patient. Tested Hypothesis: The success rate of the surgery of idiopathic macular holes larger than 400 µm is increased by the peeling of the MLI. Awaited results: To show that the success rate of the surgery of idiopathic macular holes larger than 400 µm is improved by ILM peeling. This category could then have a success rate similar to the small holes. If this difference is not proven, it will remain no justification to continue this procedure which represents little risk but which is not either without consequence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

July 18, 2008

Status Verified

July 1, 2007

Enrollment Period

3.3 years

First QC Date

September 13, 2005

Last Update Submit

July 16, 2008

Conditions

Macular Hole

Keywords

Macular holeinternal limiting membraneretinasurgery

Outcome Measures

Primary Outcomes (1)

  • percentage of success (anatomical closing, confirmed by OCT) at third postoperative month, in both groups

    at 3 months

Secondary Outcomes (4)

  • Percentage of success according to the effective success of peeling (failure, partial peeling, peeling 360°) in the peeling group of the MLI.

    at 3 months

  • Gain of ETDRS visual acuity in the third postoperative month

    at 3 months

  • Progression of cataract

    at 3 months

  • Frequency of the complications.

    at 3 months

Study Arms (2)

1

EXPERIMENTAL

With Peeling of Limiting the Intern of the Retina

Procedure: With Peeling of Limiting the Intern of the Retina

2

ACTIVE COMPARATOR

Traditional Procedure Without Peeling of Limiting

Procedure: Internal limiting membrane peeling

Interventions

With Peeling of Limiting the Intern of the RetinaPROCEDURE

With Peeling of Limiting the Intern of the Retina

1
Internal limiting membrane peelingPROCEDURE

Traditional Procedure Without Peeling of Limiting

Also known as: Traditional Procedure Without Peeling of Limiting
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age equal to or higher than 18 years
  • Patient presenting a TM idiopathic of stage 2, 3 or 4
  • Macular hole \> 400 µm in diameter
  • Patient having been informed of the objectives and constraints of the study and having signed an informed consent

You may not qualify if:

  • Patient age \< 18 years.
  • Patient having a strong myopia of the operated eye: correction carried or optimal \>6 dioptres
  • Patient MONOPHTHALMIA.
  • Patient pseudophakia presenting an "insufficient" plan capsular CRYTALLINE.
  • Patient presenting a cataract making impossible a good visualization of the bottom of eye.
  • Patient presenting an important opacification capsular.
  • Patient presenting an associated ocular pathology being able to interfere with the operation.
  • Patient presenting a TM already operated of the eye to include

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Ophtalmolgie de l'Hôpital Lariboisière

Paris, 75010, France

Location

Related Publications (1)

  • Garcin T, Gaudric A, Sikorav A, Tadayoni R, Couturier A. Internal Limiting Membrane Peeling for Large Macular Holes Induces Only Structural Remodeling without Functional Impairment Over 12 Years. Ophthalmol Retina. 2025 Mar;9(3):253-262. doi: 10.1016/j.oret.2024.09.005. Epub 2024 Sep 12.

    PMID: 39276867DERIVED

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Ramin TADAYONI, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

January 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

July 18, 2008

Record last verified: 2007-07

Locations

FR(1)