Comparision of Retinal Function and Macular Structure After 27G Pars Plana Vitrectomy With Minimal Illuminiation
NCT ID: NCT06798285
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2021-02-18
2024-06-28
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group I (standard): 20 eyes
Group I (standard): 20 eyes treated using a standard microscope (Hi-R 900, Möller-Wedel Optical GmbH)
Pars Plana Vitrectomy Standard
Group I: PPV with endoillumination set at 3.2 Lm.
Group II (3D): 20 eyes
Group II (3D): 20 eyes treated using the 3D heads-up NGENUITY 3D Visualization System (Alcon Laboratories, Inc.; Fort Worth, TX, USA)
Pars Plana Vitrectomy 3D
Group II: PPV with endoillumination set at 0.5 Lm.
Interventions
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Pars Plana Vitrectomy Standard
Group I: PPV with endoillumination set at 3.2 Lm.
Pars Plana Vitrectomy 3D
Group II: PPV with endoillumination set at 0.5 Lm.
Eligibility Criteria
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Inclusion Criteria
* Pseudophakia
* ERM without other abnormalities
* Patient's consent to participate in the project with a 6-month follow-up after surgery.
Exclusion Criteria
* AMD
* Systemic diseases known to influence retinal function (e.g., diabetes)
* Psychiatric disorders
* Advanced stages of cardiovascular diseases
* Previous PPV
* High myopia.
60 Years
80 Years
ALL
No
Sponsors
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Pomeranian Medical University Szczecin
OTHER
Responsible Party
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Locations
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II Department of Ophthalmology, Pomeranian Medical University
Szczecin, Zachodnipomorskie, Poland
Countries
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Other Identifiers
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ERM
Identifier Type: -
Identifier Source: org_study_id
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