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To evaluate the clinical outcomes and patient satisfaction of two commercially available trifocal toric intraocular lenses Primary Objective: To compare the distance-corrected intermediate visual acuity between the two trifocal toric intraocular lenses. Secondary Objectives: To assess and compare the safety of two trifocal toric intraocular lenses.
Trifocal lenses are part of the premium range of refractive-diffractive trifocal IOLs with advanced aspheric optics for excellent visual outcomes. They are single piece, posterior chamber foldable intraocular lenses. The optic is refractive-diffractive trifocal with the anterior surface being aspheric and the posterior surface with a square edge design. The lens is designed to provide all near, distance and intermediate vision and thereby reduce spectacle dependency. Toric version of trifocal intraocular lens is intended to correct astigmatism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optiflex TRIO (Biotech Europe Meditech Inc. Ltd.) | Experimental | Patients will be implanted with Optiflex TRIO (Biotech Europe Meditech Inc. Ltd.) IOL based on randomization |
|
| AcrySof® IQ PanOptix® (Alcon Laboratories, Inc.) | Active Comparator | Patients will be implanted with AcrySof® IQ PanOptix® (Alcon Laboratories, Inc.) based on randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optiflex TRIO Intraocular Lens | Device | The patients will be implanted with Optiflex TRIO IOL at this arm based on randomization. Trifocal lenses are part of the premium range of refractive-diffractive trifocal IOLs with advanced aspheric optics for excellent visual outcomes. They are single piece, posterior chamber foldable intraocular lenses. The optic is refractive-diffractive trifocal Toric with the anterior surface being aspheric and the posterior surface with a square edge design. The lens is designed to provide all near, distance and intermediate vision and thereby reduce spectacle dependency. Toric version of trifocal intraocular lens is intended to correct astigmatism |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular distance corrected intermediate visual acuity (BCIDVA) | The primary effectiveness endpoint is binocular distance corrected intermediate visual acuity (BCIDVA) at 70 cms at 6 months postoperative, with a target of equivalency between the two IOLs. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BHARGAV D JOSHI, M.Sc. | Contact | +917966823000 | 203 | bhargav.joshi@biotechhealthcare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Internationale Innovative Ophthalmochirurgie GbR | Recruiting | Düsseldorf | North Rhine-Westphalia | 40212 | Germany |
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Trifocal Toric Intraocular lens are indicated for primary implantation for visual aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia who wish to gain near, intermediate and distance vision with decreased dependency on spectacles
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|
| AcrySof® IQ PanOptix® | Device | The patients will be implanted with AcrySof® IQ PanOptix® at this arm based on randomization. Trifocal lenses are part of the premium range of refractive-diffractive trifocal IOLs with advanced aspheric optics for excellent visual outcomes. They are single piece, posterior chamber foldable intraocular lenses. The optic is diffractive trifocal with the anterior surface being aspheric and the posterior surface with a toric component. The lens is designed to provide all near, distance and intermediate vision and thereby reduce spectacle dependency. Toric version of trifocal intraocular lens is intended to correct astigmatism. |
|
| Augentagesklinik | Recruiting | Greven | North Rhine-Westphalia | 48268 | Germany |
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| Augentagesklinik | Recruiting | Rheine | North Rhine-Westphalia | 48429 | Germany |
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| Netradhama Superspeciality Eye Hospital | Not yet recruiting | Bangalore | Karnatak | 560082 | India |
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| Dr. Agarwal Eye Hospital | Recruiting | Chennai | Tamil Nadu | 600018 | India |
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| Hospital Arruzafa | Recruiting | Córdoba | Córdoba | 14012 | Spain |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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