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OpenTrials
Completed

NCT Number: NCT05085314

Comfort Operative Ocular Light Study

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Honoré Cave, Montauban, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ngenuity digital 3D microscope

Procedure

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

Conventional microscope

Procedure

Cataract surgery under topical anesthesia with a conventional microscope

Primary outcomes

  1. Glare of patients related to the light of the microscope of the patients

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Collaborators

  • Alcon Research

Registry information

Official study 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

Acronym: COOL

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 20, 2021
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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