Comfort Operative Ocular Light Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-18

Study Completion Date

2022-06-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ngenuity digital 3D microscope

Group Type EXPERIMENTAL

Ngenuity digital 3D microscope

Intervention Type PROCEDURE

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

Conventional microscope

Group Type ACTIVE_COMPARATOR

Conventional microscope

Intervention Type PROCEDURE

Cataract surgery under topical anesthesia with a conventional microscope

Interventions

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Ngenuity digital 3D microscope

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

Intervention Type PROCEDURE

Conventional microscope

Cataract surgery under topical anesthesia with a conventional microscope

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No