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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (standard): 20 eyes | Active Comparator | Group I (standard): 20 eyes treated using a standard microscope (Hi-R 900, Möller-Wedel Optical GmbH) |
|
| Group II (3D): 20 eyes | Active Comparator | Group II (3D): 20 eyes treated using the 3D heads-up NGENUITY 3D Visualization System (Alcon Laboratories, Inc.; Fort Worth, TX, USA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pars Plana Vitrectomy Standard | Procedure | Group I: PPV with endoillumination set at 3.2 Lm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioelectrical Retinal function | 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) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Structural Macula Changes | The low intensity illumination may be a cause of reduced macular structure changes | 6 months |
| Changes DBCVA (Distance Best Corrected vision) | The low intensity illumination may be a cause of beter DBCVA after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| II Department of Ophthalmology, Pomeranian Medical University | Szczecin | Zachodnipomorskie | 70-135 | Poland |
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| ID | Term |
|---|---|
| D019773 | Epiretinal Membrane |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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Patients who met the inclusion criteria were assigned to groups according to block randomization
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| Pars Plana Vitrectomy 3D | Procedure | Group II: PPV with endoillumination set at 0.5 Lm. |
|
| 6 months |