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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ngenuity digital 3D microscope | Experimental |
| |
| Conventional microscope | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ngenuity digital 3D microscope | Procedure | Cataract surgery under topical anesthesia with the Ngenuity digital 3D microscope, Alcon, Fort Worth, TX |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramin TADAYONI | Hôpital Fondation A. de Rothschild | Principal Investigator |
| Vincent GUALINO | Clinique Honoré Cave, Montauban | Study Chair |
| Aude COUTURIER | Hopital Lariboisière | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Honoré Cave | Montauban | 82000 | France | |||
| Hôpital Fondation A. de Rothschuld |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37493673 | Derived | Gualino V, Pierne K, Manassero A, Bruneau S, Couturier A, Tadayoni R. Comparing microscope light-associated glare and comfort between heads-up 3D digital and conventional microscopes in cataract surgery: a randomised, multicentre, single-blind, controlled trial. BMJ Open Ophthalmol. 2023 Jun;8(1):e001272. doi: 10.1136/bmjophth-2023-001272. Epub 2023 Jun 26. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Conventional microscope | Procedure | Cataract surgery under topical anesthesia with a conventional microscope |
|
| Paris |
| 75019 |
| France |