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Clinical Trials/NCT05113212
NCT05113212CompletedNot Applicable

Randomized, Prospective, Descriptive and Comparative Clinical Study of Macular Grasping Damage in Patients Undergoing Pars Plana Vitrectomy and Peeling of the Internal Limiting Membrane, Operated by Traditional Microscope or NGENUITY® 3D Visualization System With Heads-up Display System. A Pilot Study.

Anna Rita Daniele, MD2 sites in 1 country64 target enrollmentStarted: November 19, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
64
Locations
2
Primary Endpoint
SANFL detection
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

SANFL detection

Time Frame: 2 weeks after surgery

Post-surgical analysis of SANFL (Swelling of the Arcuate Nerve Fiber Layer) measured on infrared, blue auto-fluorescence images and OCT images of peripapillary region

Secondary Outcomes

  • ILM staining(during surgery)
  • ILM grasping(during surgery)
  • Light(during surgery)
  • BCVA(baseline, 1 month and 3 months after surgery)
  • Intraoperative time(during surgery)
  • Surgeon ergonomics(during surgery)

Investigators

Sponsor
Anna Rita Daniele, MD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Anna Rita Daniele, MD

Medical Doctor

Santa Maria della Misericordia Rovigo Hospital

Study Sites (2)

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