Clinical trial NCT05085314: Comfort Operative Ocular Light Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Ngenuity 3D digital operating system
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
Collaborators: name: Alcon Research
First posted: 2021-10-20
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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:

* 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)

Primary outcomes:
measure: Glare of patients related to the light of the microscope of the patients
timeFrame: two hours maximum after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Montauban
country: France
facility: Clinique Honoré Cave
city: Paris
country: France
facility: Hôpital Fondation A. de Rothschuld
Study officials:
affiliation: Hôpital Fondation A. de Rothschild
name: Ramin TADAYONI
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Honoré Cave, Montauban
name: Vincent GUALINO
role: STUDY_CHAIR
affiliation: Hôpital Lariboisière
name: Aude COUTURIER
role: STUDY_CHAIR
References: