COOL: Comfort Operative Ocular Light Study
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ngenuity digital 3D microscope
|
Procedure: Ngenuity digital 3D microscope
Cataract surgery under topical anesthesia with the Ngenuity digital 3D microscope, Alcon, Fort Worth, TX
|
| Active Comparator: Conventional microscope
|
Procedure: Conventional microscope
Cataract surgery under topical anesthesia with a conventional microscope
|
Outcome Measures
Primary Outcome Measures
- Glare of patients related to the light of the microscope of the patients [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)
Eligibility Criteria
Criteria
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:
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinique Honoré Cave | Montauban | France | 82000 | |
| 2 | Hôpital Fondation A. de Rothschuld | Paris | France | 75019 |
Sponsors and Collaborators
- Fondation Ophtalmologique Adolphe de Rothschild
- Alcon Research
Investigators
- Principal Investigator: Ramin TADAYONI, Hôpital Fondation A. de Rothschild
- Study Chair: Vincent GUALINO, Clinique Honoré Cave, Montauban
- Study Chair: Aude COUTURIER, Hôpital Lariboisière
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RTI_2021_7