Trials / Completed
CompletedNCT06798285
Comparision of Retinal Function and Macular Structure After 27G Pars Plana Vitrectomy With Minimal Illuminiation
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Pomeranian Medical University Szczecin · Academic / Other
- Sex
- All
- Age
- 60 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Pars Plana Vitrectomy Standard | Group I: PPV with endoillumination set at 3.2 Lm. |
| PROCEDURE | Pars Plana Vitrectomy 3D | Group II: PPV with endoillumination set at 0.5 Lm. |
Timeline
- Start date
- 2021-02-18
- Primary completion
- 2024-06-28
- Completion
- 2024-06-28
- First posted
- 2025-01-29
- Last updated
- 2025-01-29
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT06798285. Inclusion in this directory is not an endorsement.