Comfort Operative Ocular Light Study (COOL)

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Conditions

Cataract

Treatments

Procedure: Conventional microscope

Procedure: Ngenuity digital 3D microscope

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT05085314

RTI_2021_7

Details and patient eligibility

About

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).

Full 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.

Enrollment

134 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)