A Planned Study at Multiple Sites is Being Done to Compare the Results of Two Types of Trifocal Toric Intraocular Lenses Used in Cataract Surgery
NCT ID: NCT07232615
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
138 participants
INTERVENTIONAL
2021-11-22
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Optiflex TRIO (Biotech Europe Meditech Inc. Ltd.)
Patients will be implanted with Optiflex TRIO (Biotech Europe Meditech Inc. Ltd.) IOL based on randomization
Optiflex 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
AcrySof® IQ PanOptix® (Alcon Laboratories, Inc.)
Patients will be implanted with AcrySof® IQ PanOptix® (Alcon Laboratories, Inc.) based on randomization
AcrySof® 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.
Interventions
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Optiflex 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
AcrySof® 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.
Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
ALL
No
Sponsors
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Biotech Healthcare Holding Gmbh
INDUSTRY
Responsible Party
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Locations
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Internationale Innovative Ophthalmochirurgie GbR
Düsseldorf, North Rhine-Westphalia, Germany
Augentagesklinik
Greven, North Rhine-Westphalia, Germany
Augentagesklinik
Rheine, North Rhine-Westphalia, Germany
Netradhama Superspeciality Eye Hospital
Bangalore, Karnatak, India
Dr. Agarwal Eye Hospital
Chennai, Tamil Nadu, India
Hospital Arruzafa
Córdoba, Córdoba, Spain
Countries
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Central Contacts
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Facility Contacts
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Edda Clinical Study Coordinator, Optometrist
Role: primary
David Cerdan Clinical Study Coordinator, Optometrist
Role: primary
Other Identifiers
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BTVCPL-TRITORIC-2019-18
Identifier Type: -
Identifier Source: org_study_id
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