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Foveal Sparing of the ILM

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03488576
Enrollment
190
Registered
2018-04-05
Start date
2014-07-01
Completion date
2017-06-30
Last updated
2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Sensitivity

Brief summary

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.

Interventions

PROCEDUREComplete Macular Peeling

A complete peeling of the internal limiting membrane was performed

PROCEDUREMacular Peeling with Foveal Sparing

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

Sponsors

Università degli Studi di Brescia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Retinal Sensitivity (dB)12-monthMicroperimetry was done to assess macular sensitivity
Visual Acuity (LogMAR)12-monthETDRS charts were used to assess best corrected visual acuity
Central Retinal Thickness (microns)12-monthOptical Coherence Tomography will be used to assess central retinal thickness

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026