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OpenTrials
Completed

NCT Number: NCT03488576

Foveal Sparing of the ILM

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.

Completed

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Key information

Conditions

Retinal Sensitivity

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Complete Macular Peeling

Procedure

A complete peeling of the internal limiting membrane was performed

Macular Peeling with Foveal Sparing

Procedure

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

Primary outcomes

  1. Retinal Sensitivity (dB)

    Time frame: 12-month

    Microperimetry was done to assess macular sensitivity

  2. Visual Acuity (LogMAR)

    Time frame: 12-month

    ETDRS charts were used to assess best corrected visual acuity

  3. Central Retinal Thickness (microns)

    Time frame: 12-month

    Optical Coherence Tomography will be used to assess central retinal thickness

Sponsors and collaborators

Lead sponsor

Università degli Studi di Brescia

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Apr 5, 2018
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.