Comfort Operative Ocular Light Study

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Procedure: Ngenuity digital 3D microscope; Procedure: Conventional microscope

• Registration Number: NCT05085314
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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).

Detailed Description

Patients will be recruited during the preoperative consultation where the indication for cataract surgery. The allocation of the management arm (3D digital microscope or conventional microscope) will be randomized in a stratified way on the center.

Prior to his or her operative session, the surgeon will set up the microscope with his or her usual parameters.

The light intensity will be measured at the beginning of the operating session with a calibrated light meter. The type of anesthesia (pure topical or associated with intravenous sedation), the duration of the operation, intraoperative complications (frequency and type), and the possible use of an anesthesiologist to inject additional intravenous anesthetic will be collected.

Before the patient is discharged from the ambulatory surgical unit, the clinical study technician will ask the patient the 4 questions of the standardized questionnaire assessing comfort and subjective visual sensations related to the microscope light.

Study Timeline

• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-20
• Study Start: 2021-11-18
• Status Verified: 2022-06
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ngenuity digital 3D microscope	Ngenuity digital 3D microscope	-
Conventional microscope	Conventional microscope	-

Primary Outcome Measures

Name	Time	Method
Glare of patients related to the light of the microscope of the patients	two hours maximum after surgery	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)

Trial Locations

Locations (2)

Hôpital Fondation A. de Rothschuld; 🇫🇷 Paris, France

Clinique Honoré Cave; 🇫🇷 Montauban, France