CataractCOOLNCT05085314
Comfort Operative Ocular Light Study
A study testing Ngenuity digital 3D microscope and Conventional microscope in people with Cataract, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Ngenuity digital 3D microscope and Conventional microscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Nov 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique Honoré Cave
Montauban, 82000
Hôpital Fondation A. de Rothschuld
Paris, 75019
About this 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
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).
Read the 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.
- Conditions
- Cataract
- Being tested
- Ngenuity digital 3D microscope, Conventional microscope
- Keywords
- Ngenuity 3D digital operating system
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ngenuity digital 3D microscopeProcedure or surgery
Cataract surgery under topical anesthesia with the Ngenuity digital 3D microscope, Alcon, Fort Worth, TX
Conventional microscopeProcedure or surgery
Cataract surgery under topical anesthesia with a conventional microscope
| Study group | Role | What they receive |
|---|---|---|
| Ngenuity digital 3D microscope | Experimental | Not described Receives: Procedure: Ngenuity digital 3D microscope |
| Conventional microscope | Active comparator | Not described Receives: Procedure: Conventional microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: two hours maximum after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start18 Nov 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Ramin TADAYONI, Principal investigator, Hôpital Fondation A. de RothschildVincent GUALINO, Study chair, Clinique Honoré Cave, MontaubanAude COUTURIER, Study chair, Hopital Lariboisière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085314
- Sponsor's protocol ID
- RTI_2021_7
- Acronym
- COOL
- Status last verified
- Jun 2022
- First submitted
- 7 Oct 2021
- Last updated
- 1 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37493673
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05085314
- Acronym / sponsor ID
- COOL / RTI_2021_7
- Conditions
- Cataract
- Keywords
- Ngenuity 3D digital operating system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Collaborators
- Alcon Research
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ngenuity digital 3D microscope | Experimental | Procedure: Ngenuity digital 3D microscope |
| Conventional microscope | Active comparator | Procedure: Conventional microscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ngenuity digital 3D microscopeCataract surgery under topical anesthesia with the Ngenuity digital 3D microscope, Alcon, Fort Worth, TX | Procedure or surgery | Ngenuity digital 3D microscope |
| Conventional microscopeCataract surgery under topical anesthesia with a conventional microscope | Procedure or surgery | Conventional microscope |
Primary outcome
Glare of patients related to the light of the microscope of the patients
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Derived from this study: PubMed 37493673Gualino 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.
Related trials for Cataract
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
Recruiting
Clinical Evaluation of a Novel Trifocal IOL
Aphakia, Cataract
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Not yet recruitingObservational study
Postoperative Outcome Verification of Discrepant Toric IOL Calculator Recommendations After Cataract Surgery
Cataract
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramin TADAYONI principal investigator
Hôpital Fondation A. de Rothschild
Vincent GUALINO study chair
Clinique Honoré Cave, Montauban
Aude COUTURIER study chair
Hopital Lariboisière
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ngenuity digital 3D microscope and Conventional microscope in people with Cataract, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glare of patients related to the light of the microscope of the patients (time frame: two hours maximum after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05085314, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.