Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fondation Ophtalmologique Adolphe de Rothschild | NETWORK |
| StreetLab Vision | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Prospective, interventional, non-invasive, monocentric, longitudinal, non-randomized study
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Performance tasks in daily life | Diagnostic Test | Evaluation of performance tests executed by patients in real-life situations. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
Not provided
Not provided
Inclusion Criteria:
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
No use of an aid to locomotion (example: cane, etc...)
Binocular far non corrected visual acuity ≥ 8/10
Refraction at distance vision
Monovision group :
> Addition=1.25 diopter ±0.50
Multifocal group :
EDOF group :
Exclusion Criteria:
Media opacity or eye movement disorder (nystagmus) that interferes with retinal imaging data quality in the opinion of the investigator ;
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nabil BROUK | Contact | +33140021126 | nbrouk@15-20.fr | |
| Hayet SERHANE | Contact | +33140021144 | hserhane@15-20.fr |
| Name | Affiliation | Role |
|---|---|---|
| Anna GEMAHLING | Fondation Hôpital Adolphe de Rothschild | Principal Investigator |
| Erci GABISON | Fondation Hôpital Adolphe de Rothschild | Study Director |
Not provided
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Prospective, interventional, non-invasive, monocentric, longitudinal, non-randomized study
Not provided
Not provided
Not provided
Not provided
| 3 months |