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

Pomeranian Medical University Szczecin

Status: Completed

Conditions: Epiretinal Membrane

Treatments: Procedure: Pars Plana Vitrectomy 3D; Procedure: Pars Plana Vitrectomy Standard

Study type: Interventional

Funder types: Other

Identifiers

NCT06798285

ERM

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Group I (standard): 20 eyes

Active Comparator group

Description:

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

Treatment:

Procedure: Pars Plana Vitrectomy Standard

Group II (3D): 20 eyes

Active Comparator group

Description:

Group II (3D): 20 eyes treated using the 3D heads-up NGENUITY 3D Visualization System (Alcon Laboratories, Inc.; Fort Worth, TX, USA)

Treatment:

Procedure: Pars Plana Vitrectomy 3D