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Comfort Operative Ocular Light Study

NCT05085314 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2022-07-01

No results posted yet for this study

Summary

Digital 3D microscopes require less light and may be more comfortable for patients requiring cataract surgery under topical anesthesia compared to conventional microscopes.

To date, no studies have evaluated the comfort and subjective visual sensations related to the light of the 3D digital microscope in cataract surgery patients.

The purpose of this study is to evaluate the effectiveness of the Ngenuity 3D digital operating system (Alcon, Fort Worth, TX) compared to conventional microscopes on the comfort and subjective visual sensations related to of patients undergoing initial cataract surgery under topical anesthesia (pure or combined with intravenous sedation).

Conditions

  • Cataract

Interventions

PROCEDURE

Ngenuity digital 3D microscope

Cataract surgery under topical anesthesia with the Ngenuity digital 3D microscope, Alcon, Fort Worth, TX

PROCEDURE

Conventional microscope

Cataract surgery under topical anesthesia with a conventional microscope

Sponsors & Collaborators

  • Alcon Research

    collaborator INDUSTRY

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Principal Investigators

  • Ramin TADAYONI · Hôpital Fondation A. de Rothschild

  • Vincent GUALINO · Clinique Honoré Cave, Montauban

  • Aude COUTURIER · Hôpital Lariboisière

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-18
Primary Completion
2022-06-01
Completion
2022-06-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05085314 on ClinicalTrials.gov