CompletedNot Applicable

Damages From Macular Grasping During Vitrectomy Comparing Traditional and 3D Microscope

Italy64 participantsStarted 2021-11-19

Plain-language summary

Randomized, prospective, descriptive and comparative clinical study. The comparison is between a group of patients affected by macular pucker or macular hole, whose macular peeling is performed using a traditional optical microscope (Leica F40) - control arm, and a group of patients affected by macular pucker or macular hole whose macular peeling is performed by 3D heads-up microscopy system (NGenuity 3D, Alcon) - experimental arm. It is a blind study for both the operator that collects data and for the statistician.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients affected by macular pucker or macular hole, whose internal limiting membrane peeling need to be performed * Willing and able to understand and sign an informed consent * Willing and able to undergo postoperative examinations of the protocol program: * ≥ 21 years of age, of both sexes and any race Exclusion Criteria: * History of ocular trauma or amblyopia. * Other ocular pathologies (glaucoma, uveitis, diabetic retinopathy, diabetic macular edema, macular degeneration, Irvine Gass Syndrome, degenerative myopia, malformation of the optic disc, i.e.: tilted disc, optic disc pit, posterior staphyloma) * Multiple procedures programmed during the surgery * Pregnancy, lactation or programmed pregnancy during the course of the study.

What they're measuring

SANFL detection

Timeframe: 2 weeks after surgery

Trial details

NCT IDNCT05113212

SponsorAnna Rita Daniele, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-30

View on ClinicalTrials.gov More Comparison of 3D Visualization and Microscope for VR Surgery trials