II Department of Ophthalmology, Pomeranian Medical University
Szczecin, Zachodnipomorskie, 70-135, Poland
NCT Number: NCT06798285
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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Notify Me60 year–80 year
All sexes
Interventional
Not applicable
Szczecin, Zachodnipomorskie, 70-135, Poland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group I: PPV with endoillumination set at 3.2 Lm.
Group II: PPV with endoillumination set at 0.5 Lm.
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)
Time frame: 6 months
The low intensity illumination may be a cause of reduced macular structure changes
Time frame: 6 months
The low intensity illumination may be a cause of beter DBCVA after surgery
Pomeranian Medical University Szczecin
Other
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
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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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