CataractCASSIOPEENCT06168617
CAtaract ASSessment of IntrOcular Lens Objective PErformancE
A study testing Performance tasks in daily life in people with Cataract, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
Trial summary
Prospective, interventional, non-invasive, monocentric, longitudinal, non-randomized study Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Cataract
- What is being tested?
- Performance tasks in daily life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Jan 2026
- 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male / Female
- 65-75 years old
- Pseudophakia, implanted with 2 trifocal IOL or 2 EDOF IOL or with 2 monofocal IOL calculated for monovision
- Second eye surgery performed > 1 month before inclusion with stable residual refraction
- No degenerative or neurological disease
- Good understanding of the French language
Show all 19Show fewer
- No use of an aid to locomotion (example: cane, etc...)
- Binocular far non corrected visual acuity ≥ 8/10
- Refraction at distance vision
- Spherical equivalent in distance vision ≤ 0.75 diopter
- Cylinder ≤ 0.75 diopter
- Monovision group :
- > Addition=1.25 diopter ±0.50
- Multifocal group :
- Monocular far non corrected visual acuity ≥ 8/10
- ATLISA tri (Zeiss)
- EDOF group :
- Monocular far non corrected visual acuity ≥ 8/10
- Eyehance (J\&J)
Who cannot join
- Media opacity or eye movement disorder (nystagmus) that interferes with retinal imaging data quality in the opinion of the investigator ;
- Media opacity or eye movement disorder (nystagmus) that interferes with retinal imaging data quality in the opinion of the investigator ;
- Any concurrent intraocular condition that, in the opinion of the investigator would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results ;
- Known systemic illness which in the opinion of the investigator will prevent from actively participating in the study ;
- Concomitant treatment in either eye (concomitant use of vitamins/supplements is not excluded) ;
- Inability to comply with study task instructions or study visits ;
Show all 14Show fewer
- Medication that may cause motor, visual or cognitive impairment (PSAs, neuroleptics, etc.) or interfere with study evaluations ;
- Other uncontrolled ophthalmic conditions that may interfere with study evaluation ;
- Participation in another clinical trial that may interfere with the present study ;
- Cognitive impairment, illiteracy, and subjects who do not speak the national language ;
- Paralysis may compromise ability to perform manual grasping tasks ;
- Pregnant or breastfeeding woman ;
- Patient under legal protection ("curatelle" or "tutelle") ;
- Patient denied freedom by a legal or administrative order.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility Study of Tests, on the Model of Real-life Daily Tasks, Measuring the Performance of Different Vision Restoration Strategies, After Cataract Surgical Treatment With Different Types of Intraocular Lens Implants.
Prospective, interventional, non-invasive, monocentric, longitudinal, non-randomized study
Read the detailed description
There are many strategies for restoring vision after cataract surgery. They all involve the use of intraocular lenses (IOLs) to correct a single focal length (monofocal lenses) or several focal lengths (multifocal lenses). Each focal length corrected by the implants represents a distance of clear vision for patients. The complexity of the optical design and the neurosensory adaptation required for this restoration may present a downside, as implant patients may complain of light halos, glare or problems with depth perception, depending on the case.
Existing validated techniques are not sufficient to accurately assess the benefits or difficulties in the daily lives of elderly patients, the a With this project, the patient and his or her autonomy become the focus of the evaluation of IOL performance, particularly for IOLs of recent design, which makes it possible to better characterise the consequences of their implantation. PerfO studies of IOLs used in cataract surgery will be based on objectives tasks inspired by daily life performed by patients according to Street Lab procedures.
- Conditions
- Cataract
- Being tested
- Performance tasks in daily life
- Keywords
- Cataract, Intraocular Lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance tasks in daily lifeDiagnostic test
Evaluation of performance tests executed by patients in real-life situations.
| Study group | Role | What they receive |
|---|---|---|
| Pilot phase | Experimental | 5 patients of both 3 groups will perform the parametric studying tasks. This phase aims at determine the feasibility of the tasks according to their parameters : Guided walk, visuo-manual task and posturography. Receives: Diagnostic Test: Performance tasks in daily life |
| Validation phase | Experimental | 20 patients of both 3 groups will perform these performance tasks. This phase is designed to evaluate the performance tests executed by patients in real-life situations. Receives: Diagnostic Test: Performance tasks in daily life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locomotion - Guided walk
The operator measure the success and completion rates for daily life tests:
The performance is measured with the walking speed and the foot placement precision. The walking balance is also evaluated by recording the pelvis position.
Measured: 3 months
Static and dynamic posturography with optical flow:
Postural control will be described by the Root Mean Square (RMS) of body sway in sagittal and coronal plans, the path length of the projection of the center of mass (CoM), the sway area described by the confidence ellipse which is the region that contains 95% of all COM samples. To better understand the visual, vestibular and somatosensory contributions on postural control, Romberg quotient (QR), Visual ratio (ViR), vestibular ratio (VeR) and somatosensory ratio (SR) will be calculated thanks to sensory conditions. Correlations with visual functions will be realized and postural deficits will be integrated into the locomotion score as a covariable.
Measured: 3 months
Visuo-manual task
The variables analyzed :the duration of the visual search, which will be an indicator of the quality and ease of vision ; the duration of the grasping movement, which will be an indicator of the ease of the approach movement towards a low contrast object ; the duration between the seizure of the object and its deposit, which will be an indicator of the sensitivity to contrast ; the number of errors (wrong object grasped, object dropped, ...), will be an indicator of insufficient vision to perform the task.
Measured: 3 months
Quality of life
French version Adapted Catquest-9SF questionnaire. It is a psychometric questionnaire specifically designed for cataracts. It assesses patient satisfaction with their eyesight. It consists of nine questions divided into two parts. The first part concerns two questions on the general quality of vision perceived by the patient, and the second part concerns seven questions on the difficulties that vision can cause on daily activities. The first page contains an explanatory note on the questionnaire. The patients' answers are divided into four equal boxes designating the degree of difficulty: very great difficulty, great difficulty, moderate difficulty and no difficulty.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, interventional, non-invasive, monocentric, longitudinal, non-randomized study
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Ophtalmologique Adolphe de Rothschild, StreetLab Vision
- Responsible party
- Sponsor
- Investigators
- Anna GEMAHLING, Principal investigator, Fondation Hôpital Adolphe de RothschildErci GABISON, Study director, Fondation Hôpital Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168617
- Sponsor's protocol ID
- P22-08
- Acronym
- CASSIOPEE
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Tests, on the Model of Real-life Daily Tasks, Measuring the Performance of Different Vision Restoration Strategies, After Cataract Surgical Treatment With Different Types of Intraocular Lens Implants.
- ClinicalTrials.gov ID
- NCT06168617
- Acronym / sponsor ID
- CASSIOPEE / P22-08
- Conditions
- Cataract
- Keywords
- Cataract, Intraocular Lens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Collaborators
- Fondation Ophtalmologique Adolphe de Rothschild, StreetLab Vision
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 13 Dec 2023 (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.
Prospective, interventional, non-invasive, monocentric, longitudinal, non-randomized study
Detailed description
There are many strategies for restoring vision after cataract surgery. They all involve the use of intraocular lenses (IOLs) to correct a single focal length (monofocal lenses) or several focal lengths (multifocal lenses). Each focal length corrected by the implants represents a distance of clear vision for patients. The complexity of the optical design and the neurosensory adaptation required for this restoration may present a downside, as implant patients may complain of light halos, glare or problems with depth perception, depending on the case.
Existing validated techniques are not sufficient to accurately assess the benefits or difficulties in the daily lives of elderly patients, the a With this project, the patient and his or her autonomy become the focus of the evaluation of IOL performance, particularly for IOLs of recent design, which makes it possible to better characterise the consequences of their implantation. PerfO studies of IOLs used in cataract surgery will be based on objectives tasks inspired by daily life performed by patients according to Street Lab procedures.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, interventional, non-invasive, monocentric, longitudinal, non-randomized study
| Arm | Type | Receives |
|---|---|---|
| Pilot phase | Experimental | Diagnostic Test: Performance tasks in daily life5 patients of both 3 groups will perform the parametric studying tasks. This phase aims at determine the feasibility of the tasks according to their parameters : Guided walk, visuo-manual task and posturography. |
| Validation phase | Experimental | Diagnostic Test: Performance tasks in daily life20 patients of both 3 groups will perform these performance tasks. This phase is designed to evaluate the performance tests executed by patients in real-life situations. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (19 listed)
- Male / Female
- 65-75 years old
- Pseudophakia, implanted with 2 trifocal IOL or 2 EDOF IOL or with 2 monofocal IOL calculated for monovision
- Second eye surgery performed > 1 month before inclusion with stable residual refraction
- No degenerative or neurological disease
Key exclusion criteria (14 listed)
- Media opacity or eye movement disorder (nystagmus) that interferes with retinal imaging data quality in the opinion of the investigator ;
- Media opacity or eye movement disorder (nystagmus) that interferes with retinal imaging data quality in the opinion of the investigator ;
- Any concurrent intraocular condition that, in the opinion of the investigator would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results ;
- Known systemic illness which in the opinion of the investigator will prevent from actively participating in the study ;
- Concomitant treatment in either eye (concomitant use of vitamins/supplements is not excluded) ;
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 |
|---|---|---|
| Performance tasks in daily lifeEvaluation of performance tests executed by patients in real-life situations. | Diagnostic test | Pilot phase, Validation phase |
Primary outcome
Locomotion - Guided walk
Time frame: 3 months
The operator measure the success and completion rates for daily life tests: The performance is measured with the walking speed and the foot placement precision. The walking balance is also evaluated by recording the pelvis position.
Static and dynamic posturography with optical flow:
Time frame: 3 months
Postural control will be described by the Root Mean Square (RMS) of body sway in sagittal and coronal plans, the path length of the projection of the center of mass (CoM), the sway area described by the confidence ellipse which is the region that contains 95% of all COM samples. To better understand the visual, vestibular and somatosensory contributions on postural control, Romberg quotient (QR), Visual ratio (ViR), vestibular ratio (VeR) and somatosensory ratio (SR) will be calculated thanks to sensory conditions. Correlations with visual functions will be realized and postural deficits will be integrated into the locomotion score as a covariable.
Visuo-manual task
Time frame: 3 months
The variables analyzed :the duration of the visual search, which will be an indicator of the quality and ease of vision ; the duration of the grasping movement, which will be an indicator of the ease of the approach movement towards a low contrast object ; the duration between the seizure of the object and its deposit, which will be an indicator of the sensitivity to contrast ; the number of errors (wrong object grasped, object dropped, ...), will be an indicator of insufficient vision to perform the task.
Quality of life
Time frame: 3 months
French version Adapted Catquest-9SF questionnaire. It is a psychometric questionnaire specifically designed for cataracts. It assesses patient satisfaction with their eyesight. It consists of nine questions divided into two parts. The first part concerns two questions on the general quality of vision perceived by the patient, and the second part concerns seven questions on the difficulties that vision can cause on daily activities. The first page contains an explanatory note on the questionnaire. The patients' answers are divided into four equal boxes designating the degree of difficulty: very great difficulty, great difficulty, moderate difficulty and no difficulty.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
Anna GEMAHLING principal investigator
Fondation Hôpital Adolphe de Rothschild
Erci GABISON study director
Fondation Hôpital Adolphe de Rothschild
Questions about this trial
What is this clinical trial studying?
A study testing Performance tasks in daily life in people with Cataract, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
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 19 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nabil BROUK (+33140021126, nbrouk@15-20.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locomotion - Guided walk (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2023.