Epiretinal Membrane
Conditions
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).
Interventions
PROCEDUREPars Plana Vitrectomy Standard
Group I: PPV with endoillumination set at 3.2 Lm.
PROCEDUREPars Plana Vitrectomy 3D
Group II: PPV with endoillumination set at 0.5 Lm.
Sponsors
Pomeranian Medical University Szczecin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients who met the inclusion criteria were assigned to groups according to block randomization
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bioelectrical Retinal function | 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
| Measure | Time frame | Description |
|---|---|---|
| Structural Macula Changes | 6 months | The low intensity illumination may be a cause of reduced macular structure changes |
| Changes DBCVA (Distance Best Corrected vision) | 6 months | The low intensity illumination may be a cause of beter DBCVA after surgery |
Countries
Poland
Outcome results
None listed