Ignite Creation Date:
2025-12-18 @ 9:51 AM
Ignite Modification Date:
2025-12-23 @ 10:13 PM
Study NCT ID:
NCT05085314
Status:
None
Last Update Posted:
2022-07-01 00:00:00
First Post:
2021-10-07 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comfort Operative Ocular Light Study
Sponsor:
None
Organization:
Study Overview
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
Status:
None
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COOL
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: