Comfort Operative Ocular Light Study

Study Overview
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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).

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.

Official Title
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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

Conditions
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Cataract

Intervention / Treatment
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* Procedure: Ngenuity digital 3D microscope
* Procedure: Conventional microscope


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ngenuity digital 3D microscope<br> | Procedure: Ngenuity digital 3D microscope<br>* Cataract surgery under topical anesthesia with the Ngenuity digital 3D microscope, Alcon, Fort Worth, TX<br>|
| Active Comparator: Conventional microscope<br> | Procedure: Conventional microscope<br>* Cataract surgery under topical anesthesia with a conventional microscope<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ngenuity 3D digital operating system