Comfort Operative Ocular Light Study (COOL)

Prospective Multicenter Randomized Controlled 1:1 Study Evaluating the Efficacy of a 3D Digital Operating Microscope Compared to Conventional Microscopes Microscopes on the Comfort and Subjective Visual Sensations of the Patients Related to the Microscope Light During Initial Cataract Surgery Under Topical Anesthesia Topical Anesthesia

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).

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Procedure: Ngenuity digital 3D microscope; Procedure: Conventional microscope

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 Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montauban, France, 82000
    • Clinique Honoré Cave
  • Paris, France, 75019
    • Hôpital Fondation A. de Rothschuld

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ngenuity digital 3D microscope	Procedure: Ngenuity digital 3D microscope; Cataract surgery under topical anesthesia with the Ngenuity digital 3D microscope, Alcon, Fort Worth, TX
ACTIVE_COMPARATOR: Conventional microscope	Procedure: Conventional microscope; Cataract surgery under topical anesthesia with a conventional microscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Ramin TADAYONI, Hôpital Fondation A. de Rothschild; Study Chair: Vincent GUALINO, Clinique Honoré Cave, Montauban; Study Chair: Aude COUTURIER, Hôpital Lariboisière

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 18, 2021
• Primary Completion (ACTUAL): June 1, 2022
• Study Completion (ACTUAL): June 1, 2022

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (ACTUAL): October 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Ngenuity 3D digital operating system
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: RTI_2021_7

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No