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Outcomes Based on the Pre-operative Integrity of IS/OS Junction in Idiopathic Epimacular Membrane Surgery

NCT04158791 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2019-11-13

No results posted yet for this study

Summary

The aim of this study is to evaluate whether the pre-operative integrity or not of the inner segment (IS) and outer segment (OS) photoreceptoral junction may influence the post-operative visual acuity, the macular morphology (assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT)) and function (evaluated by Multifocal Electroretinogram -mfERG) in patients with idiopathic epimacular membrane (EMM) followed-up for 6-month.

In this observational prospective study, EMM patients are enrolled. They are divided into 2 groups in relationship to the pre-operative integrity of the SD-OCT IS/OS junction: the group with an intact IS/OS junction (EMM-I Group) and the group with a disrupted IS/OS junction (EMM-D Group). For each enrolled patient, visual acuity (VA), mfERG and SD-OCT were assessed at baseline (pre-operative) and after 1, 3 and 6 months of follow-up after surgical treatment for EMM (pars plana vitrectomy with EMM removal and internal limiting membrane peeling).

Conditions

  • Epimacular Membrane

Interventions

PROCEDURE

pars plana vitrectomy with epimacular membrane removal and internal limiting membrane peeling

25-gauge pars plana vitrectomy with a solution of 0.15% trypan blue, 0.025% brilliant blue G, 4% polyethylene glycol (MembraneBlue Dual) assisted ERM/ILM removal performed by a single surgeon (GV); no air-fluid exchange was performed during surgery. In phakic eyes, phacoemulsification with intraocular lens implantation was performed at the time of vitrectomy.

Sponsors & Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    lead OTHER

Principal Investigators

  • Luciano Quaranta, Professor · IRCCS Policlinico San Matteo

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-25
Primary Completion
2019-02-15
Completion
2019-07-09

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04158791 on ClinicalTrials.gov