Foveal Sparing of the ILM

March 28, 2018 updated by: Francesco Semeraro, Università degli Studi di Brescia

Macular Peeling With Foveal Sparing of the Internal Limiting Membrane: A Pilot Study

To compare the retinal sensitivity of complete internal limiting membrane (ILM) peeling versus foveal sparing ILM peeling during vitrectomy for epiretinal membrane or macular hole.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • provision of written informed consent
  • age > 60 years
  • presence of idiopathic macular pucker or macular hole documented by OCT

Exclusion Criteria:

  • any prior intraocular surgery
  • pathologic myopia (> 7 diopters)
  • age related macular degeneration
  • glaucoma and diabetic retinopathy or any other retinal vascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Complete Peeling
Patient underwent scheduled vitrectomy for epiretinal membrane or macular hole with complete macular peeling of the internal limiting membrane.
Procedure: Complete Macular Peeling
A complete peeling of the internal limiting membrane was performed
Experimental: Foveal Sparing
Patient underwent scheduled vitrectomy for epiretinal membrane or macular hole with partial peeling the internal limiting membrane (foveal sparing).
Procedure: Macular Peeling with Foveal Sparing
A partial peeling of the internal limiting membrane was performed, sparing the fovea.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal Sensitivity (dB)
Time Frame: 12-month
Microperimetry was done to assess macular sensitivity
12-month
Visual Acuity (LogMAR)
Time Frame: 12-month
ETDRS charts were used to assess best corrected visual acuity
12-month
Central Retinal Thickness (microns)
Time Frame: 12-month
Optical Coherence Tomography will be used to assess central retinal thickness
12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Brescia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

March 28, 2018

First Submitted That Met QC Criteria

March 28, 2018

First Posted (Actual)

April 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitreo003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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