Foveal Sparing of the ILM

NCT ID: NCT03488576

Last Updated: 2018-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-01

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Retinal Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This was a prospective study including ninety-one eyes of 190 phakic patients scheduled to undergo vitrectomy for idiopathic macular pucker or macular hole, from July 2014 to December 2016. Patients were randomized in a 1:1 ratio to complete peeling of the ILM (CP group) or foveal sparing (FS group).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Complete Peeling

Patient underwent scheduled vitrectomy for epiretinal membrane or macular hole with complete macular peeling of the internal limiting membrane.

Group Type ACTIVE_COMPARATOR

Complete Macular Peeling

Intervention Type PROCEDURE

A complete peeling of the internal limiting membrane was performed

Foveal Sparing

Patient underwent scheduled vitrectomy for epiretinal membrane or macular hole with partial peeling the internal limiting membrane (foveal sparing).

Group Type EXPERIMENTAL

Macular Peeling with Foveal Sparing

Intervention Type PROCEDURE

A partial peeling of the internal limiting membrane was performed, sparing the fovea.

Interventions

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Complete Macular Peeling

A complete peeling of the internal limiting membrane was performed

Intervention Type PROCEDURE

Macular Peeling with Foveal Sparing

A partial peeling of the internal limiting membrane was performed, sparing the fovea.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Brescia

OTHER

Sponsor Role lead

Responsible Party

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Francesco Semeraro

Francesco Semeraro; MD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Vitreo003

Identifier Type: -

Identifier Source: org_study_id

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