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

NCT06798285 | Completed

• 1 other identifier: ERM
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Epiretinal Membrane

Outcome Measures

Primary Outcomes (1)

• Bioelectrical Retinal function

  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 Outcomes (2)

• Structural Macula Changes

  6 months

• Changes DBCVA (Distance Best Corrected vision)

  6 months

Study Arms (2)

Group I (standard): 20 eyes

ACTIVE COMPARATOR

Group I (standard): 20 eyes treated using a standard microscope (Hi-R 900, Möller-Wedel Optical GmbH)

Procedure: Pars Plana Vitrectomy Standard

Group II (3D): 20 eyes

ACTIVE COMPARATOR

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

Interventions

Pars Plana Vitrectomy Standard PROCEDURE

Group I: PPV with endoillumination set at 3.2 Lm.

Group I (standard): 20 eyes

Pars Plana Vitrectomy 3D PROCEDURE

Group II: PPV with endoillumination set at 0.5 Lm.

Group II (3D): 20 eyes

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

II Department of Ophthalmology, Pomeranian Medical University

Szczecin, Zachodnipomorskie, 70-135, Poland

Location

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who met the inclusion criteria were assigned to groups according to block randomization

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 29, 2025
• Study Start: February 18, 2021
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)