Not provided
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 |
|---|---|
| CEISO | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The objectives of the study is to evaluate efficacy and long-term safety of the Lucidis lens. Through this study, the objective is to obtain an up-to-date clinical evaluation of the medical device thus supplementing data from experimental trials. Clinical and functional changes in the implanted eyes among a patient population in which the opaque crystalline lens resulting from cataract was removed and replaced by a Lucidis IOL will be described.
Refractory function in patients with a cataract is mainly restored by implanting intra-ocular lenses (IOL) destined to replace the crystalline lens. While new surgical techniques for removing the crystalline lens have been developed, these lenses have been considerably perfected to resemble the natural crystalline lens as closely as possible.
The objectives of the study is to evaluate efficacy and long-term safety of the Lucidis lens. Through this study, the objective is to obtain an up-to-date clinical evaluation of the medical device thus supplementing data from experimental trials. Clinical and functional changes in the implanted eyes among a patient population in which the opaque crystalline lens resulting from cataract was removed and replaced by a Lucidis IOL will be described.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lucidis Intra-ocular lens (IOL) | Adult patients with significant reduction in visual acuity and/or visual comfort from cataract who will receive Lucidis Intra-ocular lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical implantation of intra ocular lens | Device | Cataract surgery may be indicated when the cataract reduces visual function to a level that interferes with everyday activities of the patient leading the patient to desire a surgical intervention to improve its vision. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity measure BCVA photopic | Far Best Corrected Visual Acuity in photopic conditions | 1 year |
| Visual acuity measure UCVA photopic | Near, intermediate and far Uncorrected visual acuity in photopic conditions | 1 year |
| Visual acuity measure BCVA mesopic | Far Best Corrected Visual Acuity in mesopic conditions | 1 year |
| Visual acuity measure UCVA mesopic | Near, intermediate and far Uncorrected visual acuity in mesopic conditions | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast sensitivity measure photopic | Contrast sensitivity in photopic conditions | 1 year |
| Contrast sensitivity measure mesopic | Contrast sensitivity in mesopic conditions |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult patients with significant reduction in visual acuity and/or visual comfort from cataract requiring intra ocular lens implantation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kate Hashemi, Pr | Contact | +41 21 626 81 11 | kattayoon.hashemi@fa2.ch |
| Name | Affiliation | Role |
|---|---|---|
| Kate Hashemi, Pr | Institut jules gonin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Jules Gonin | Recruiting | Lausanne | 1004 | Switzerland |
Not provided
| Label | URL |
|---|---|
| SAV IOL website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2020 | Feb 8, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 4, 2020 | Feb 17, 2021 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 year |
| Safety assessment | Adverse reactions | 1 year |