Comparision of Retinal Function and Macular Structure After 27G Pars Plana Vitrectomy With Minimal Illuminiation (ERM)

January 28, 2025 updated by: Pomeranian Medical University Szczecin

Comparision of Retinal Function and Macular Structure After 27G Pars Plana Vitrectomy With Minimal Heads-up Versus Standard Illuminiation in Patients With Idiopthic Epiretinal Membranes

Purpose: To analyze the clinical benefits of using the NGENUITY 3D Visualization System in vitreoretinal surgery with low levels of endo-illumination, focusing on functional and structural retinal protection in patients with idiopathic epiretinal membranes (ERM).

Design: Prospective, randomized, comparative study. Methods: Forty pseudophakic patients (29♀, 11♂; age 60-80 years) with ERM underwent 27G pars plana vitrectomy (PPV) and were randomly divided into two groups: Group I (20 eyes, stand-ard microscope [Hi-R 900], endo-illumination 3.2 Lm) and Group II (20 eyes, 3D heads-up NGE-NUITY system, endo-illumination 0.5 Lm). Preoperative and 6-month postoperative evaluations included slit-lamp examination, intraocular pressure (IOP, Pascal tonometer), Distance Best Correct-ed Visual Acuity (DBCVA, logMAR), Central Subfield Thickness (CST), Retinal Nerve Fiber Layer Thickness (RNFL, OCT), Pattern ERG (PERG), multifocal ERG (mfERG), flash ERG (ERG, IS-CEV standards), and retinal sensitivity (HFA macula test). Surgery time, xenon light exposure, ERM/ILM peeling time, fundus autofluorescence (FAF), metamorphopsia incidence, and intra-/postoperative adverse events were analyzed. Results were statistically evaluated (p < 0.05).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Zachodnipomorskie
      • Szczecin, Zachodnipomorskie, Poland, 70-135
        • II Department of Ophthalmology, Pomeranian Medical University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • DBCVA > 0.1 (Snellen charts)
  • Pseudophakia
  • ERM without other abnormalities
  • Patient's consent to participate in the project with a 6-month follow-up after surgery.

Exclusion Criteria:

  • Glaucoma
  • AMD
  • Systemic diseases known to influence retinal function (e.g., diabetes)
  • Psychiatric disorders
  • Advanced stages of cardiovascular diseases
  • Previous PPV
  • High myopia.

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: Group I (standard): 20 eyes
Group I (standard): 20 eyes treated using a standard microscope (Hi-R 900, Möller-Wedel Optical GmbH)
Procedure: Pars Plana Vitrectomy Standard
Group I: PPV with endoillumination set at 3.2 Lm.
Active Comparator: Group II (3D): 20 eyes
Group II (3D): 20 eyes treated using the 3D heads-up NGENUITY 3D Visualization System (Alcon Laboratories, Inc.; Fort Worth, TX, USA)
Procedure: Pars Plana Vitrectomy 3D
Group II: PPV with endoillumination set at 0.5 Lm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioelectrical Retinal function
Time Frame: 6 months
The low intensity of endoillumination (0.5 Lm) utilized in PPV with the NGENUITY 3D system may reduce retinal phototoxicity compared to the higher intensity of light (3.2 Lm)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Structural Macula Changes
Time Frame: 6 months
The low intensity illumination may be a cause of reduced macular structure changes
6 months
Changes DBCVA (Distance Best Corrected vision)
Time Frame: 6 months
The low intensity illumination may be a cause of beter DBCVA after surgery
6 months

Collaborators and Investigators

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

Sponsor

Pomeranian Medical University Szczecin

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)

February 18, 2021

Primary Completion (Actual)

June 28, 2024

Study Completion (Actual)

June 28, 2024

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERM

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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