Comfort Operative Ocular Light Study

Cataract Clinical Trial

— COOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05085314
• Other study ID #: RTI_2021_7
• Status: Completed
• Phase: N/A
• Start date: November 18, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2022
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• Ngenuity digital 3D microscope
Cataract surgery under topical anesthesia with the Ngenuity digital 3D microscope, Alcon, Fort Worth, TX
• Conventional microscope
Cataract surgery under topical anesthesia with a conventional microscope

Locations

Country	Name	City	State
France	Clinique Honoré Cave	Montauban
France	Hôpital Fondation A. de Rothschuld	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild	Alcon Research

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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