Comfort Operative Ocular Light Study

NCT05085314 | Completed

• 1 other identifier: RTI_2021_7
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Ngenuity 3D digital operating system

Outcome Measures

Primary Outcomes (1)

• Glare of patients related to the light of the microscope of the patients

  Patient response to the question "Were you dazzled by light during surgery?" rated on a numerical scale from 0 (Not at all) to 10 (Yes, very much)

  two hours maximum after surgery

Study Arms (2)

Ngenuity digital 3D microscope

EXPERIMENTAL

Procedure: Ngenuity digital 3D microscope

Conventional microscope

ACTIVE COMPARATOR

Procedure: Conventional microscope

Interventions

Ngenuity digital 3D microscope PROCEDURE

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

Ngenuity digital 3D microscope

Conventional microscope PROCEDURE

Cataract surgery under topical anesthesia with a conventional microscope

Conventional microscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for a first surgery (= first eye to be operated) of cataract alone under topical anesthesia (pure or associated with intravenous sedation)
• Express consent to participate in the study

You may not qualify if:

• Patient benefiting from a legal protection measure
• Patient with comprehension problems or who does not understand French well
• Pregnant or breastfeeding woman
• Indication for another surgery on the operated side (e.g. vitrectomy combined with cataract surgery)

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead
• Alcon Research: collaborator

Study Sites (2)

Clinique Honoré Cave

Montauban, 82000, France

Location

Hôpital Fondation A. de Rothschuld

Paris, 75019, France

Location

Related Publications (1)

• Gualino V, Pierne K, Manassero A, Bruneau S, Couturier A, Tadayoni R. Comparing microscope light-associated glare and comfort between heads-up 3D digital and conventional microscopes in cataract surgery: a randomised, multicentre, single-blind, controlled trial. BMJ Open Ophthalmol. 2023 Jun;8(1):e001272. doi: 10.1136/bmjophth-2023-001272. Epub 2023 Jun 26.

  PMID: 37493673 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Ramin TADAYONI

  Hôpital Fondation A. de Rothschild

  PRINCIPAL INVESTIGATOR

• Vincent GUALINO

  Clinique Honoré Cave, Montauban

  STUDY CHAIR

• Aude COUTURIER

  Hôpital Lariboisière

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: November 18, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

FR (2)