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
Not provided
| Name | Class |
|---|---|
| Sengi | INDUSTRY |
Not provided
Not provided
Not provided
This study is a prospective, randomized, two-arm, single-center, single-surgeon, double-masked (subject and assessor) comparative study. It involves bilateral implantation of intraocular lenses (IOLs), comparing Clareon TruPlus IOL and Tecnis Eyhance IOLs in normal cataract patients. The study will be conducted at one site and will include a pre-operative visit and a 3-month post-operative assessment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon TruPlus |
| ||
| Tecnis Eyhance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clareon TruPlus | Device | Bilateral implantation |
| |
| Tecnis Eyhance |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular corrected distance visual acuity (CDVA) | 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular distance-corrected intermediate visual acuity (DCIVA) at 66cm | 3 months postoperatively | |
| Binocular uncorrected distance visual acuity (UDVA) | 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular photopic BCDVA with pinhole | dominant eye only, dilated with cyclopentolate 1% | 3 months postoperatively |
| Binocular AULCSF (area under the log contrast sensitivity function) under photopic conditions without glare |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult patients with bilateral age-related cataracts eligible for planned bilateral cataract removal and IOL implantation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maryann Thomas | Contact | 770-532-4444 | maryann.thomas@ngeye.com |
| Name | Affiliation | Role |
|---|---|---|
| Clayton Blehm, MD | North Georgia Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Georgia Eye Associates | Gainesville | Georgia | 30501 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
Bilateral implantation |
|
| 3 months postoperatively |
| Binocular photopic DCNVA (40cm) | 3 months postoperatively |
| Binocular photopic UDVA | 3 months postoperatively |
| Binocular photopic UIVA (66cm) | 3 months postoperatively |
| Binocular mesopic BCDVA | 3 months postoperatively |
| Binocular mesopic DCIVA (66cm) | 3 months postoperatively |
| Binocular mesopic DCIVA (66cm) | Monocular distance corrected defocus curve (dominant eye) | 3 months postoperatively |
| Binocular AULCSF (area under the log contrast sensitivity function) under mesopic conditions | 3 months postoperatively |
| Pupil size (in mm) | Measured with a pupilometer | 3 months postoperatively |
| Manifest Refraction (in diopters) | 3 months postoperatively |
| Visual disturbances questionnaire | Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances. | 3 months postoperatively |
| Satisfaction questionnaire | The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction. | 3 months postoperatively |