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OpenTrials
Completed

NCT Number: NCT06798285

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

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).

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

II Department of Ophthalmology, Pomeranian Medical University

Szczecin, Zachodnipomorskie, 70-135, Poland

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Pars Plana Vitrectomy Standard

Procedure

Group I: PPV with endoillumination set at 3.2 Lm.

Pars Plana Vitrectomy 3D

Procedure

Group II: PPV with endoillumination set at 0.5 Lm.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Structural Macula Changes

    Time frame: 6 months

    The low intensity illumination may be a cause of reduced macular structure changes

  2. Changes DBCVA (Distance Best Corrected vision)

    Time frame: 6 months

    The low intensity illumination may be a cause of beter DBCVA after surgery

Sponsors and collaborators

Lead sponsor

Pomeranian Medical University Szczecin

Other

Registry information

Official study title

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

Acronym: ERM

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

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.

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