Astigmatism, Cataract, Presbyopia Correction
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEOptiflex TRIO Intraocular Lens
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
DEVICEAcrySof® IQ PanOptix®
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.
Sponsors
Biotech Healthcare Holding Gmbh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age of patient \>21 Years 2. Patient diagnosed with cataract. 3. Patient must have preoperative regular corneal astigmatism between 0.75 to 4.5 D as per corneal topography or keratometry 4. Calculated IOL power is within the range of investigational IOLs. 5. Patient willing to sign inform consent form. 6. Clear intraocular media other than cataract. 7. Female participants of childbearing potential must be willing to ensure that they use effective contraception during the study.
Exclusion criteria
1. Previous intraocular or corneal surgery. 2. Traumatic cataract 3. Pregnancy (as stated by patient) or lactation. 4. Concurrent participation in another drug or device investigation. 5. Irregular astigmatism. 6. Patient receiving chlorquine treatment. 7. Subjects with any systemic disease that could increase operative risk or confound the outcome. 8. Active ocular disease in the operative eye other than cataract. 9. Vulnerable subjects as defined in section 12.3.9. 10. Corneal Astigmatism \> 4.5 D
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular distance corrected intermediate visual acuity (BCIDVA) | 6 months | 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. |
Countries
Germany, India, Spain
Contacts
Primary ContactBHARGAV D JOSHI, M.Sc.
Outcome results
None listed