Presbyopia CorrectionNCT07232615
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
A study testing Optiflex TRIO Intraocular Lens and AcrySof® IQ PanOptix® in people with Presbyopia Correction and Astigmatism, run by Biotech Healthcare Holding Gmbh at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Presbyopia Correction, Astigmatism, Cataract
- What is being tested?
- Optiflex TRIO Intraocular Lens and AcrySof® IQ PanOptix®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 22 Nov 2021to Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of patient >21 Years
- Patient diagnosed with cataract.
- Patient must have preoperative regular corneal astigmatism between 0.75 to 4.5 D as per corneal topography or keratometry
- Calculated IOL power is within the range of investigational IOLs.
- Patient willing to sign inform consent form.
- Clear intraocular media other than cataract.
- Female participants of childbearing potential must be willing to ensure that they use effective contraception during the study.
Who cannot join
- Previous intraocular or corneal surgery.
- Traumatic cataract
- Pregnancy (as stated by patient) or lactation.
- Concurrent participation in another drug or device investigation.
- Irregular astigmatism.
- Patient receiving chlorquine treatment.
Show all 10Show fewer
- Subjects with any systemic disease that could increase operative risk or confound the outcome.
- Active ocular disease in the operative eye other than cataract.
- Vulnerable subjects as defined in section 12.3.9.
- Corneal Astigmatism > 4.5 D
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
Germany3 sites, 3 recruiting
- Recruiting
Internationale Innovative Ophthalmochirurgie GbR
Düsseldorf, North Rhine-Westphalia, 40212
Clinical Study Coordinator, optometrist, 0049 0211 6006600, m.kirca@augenchirurgie.clinic
Dr. Detlev Breyer, Cataract & Refractive Surgeon
- Recruiting
Augentagesklinik
Greven, North Rhine-Westphalia, 48268
Edda Clinical Study Coordinator, Optometrist, 0049 0800 3 100 900
Dr. Karen Sophie Glandorf, MD
- Recruiting
Augentagesklinik
Rheine, North Rhine-Westphalia, 48429
Clinical Study Coordinator, optometrist, 0049 0 800 3 100 900, a.gerling@precise.vision
Dr. Florian Kretz, MD, FEBO
India2 sites, 2 recruiting
- Not yet recruiting
Netradhama Superspeciality Eye Hospital
Bangalore, Karnatak, 560082
Aditi chowdhary, Optometrist, +9196935 10981, research@nethradhama.org
Dr. Sri Ganesh, Cataract & Refractive Surgeon
- Recruiting
Dr. Agarwal Eye Hospital
Chennai, Tamil Nadu, 600018
Shalini Ramasamy, Optometrist, +91 82202 87800, shalini.r@dragarwal.com
Dr. Ashvin Agarwal, M.S. (Opthalmology)
Spain1 site, 1 recruiting
- Recruiting
Hospital Arruzafa
Córdoba, Córdoba, 14012
David Cerdan Clinical Study Coordinator, Optometrist, 0034 957 40 10 40, dcerdan@hospitalarruzafa.com
Antonio Cano Ortiz, Cataract & Refractive Surgeon
About this study
Official title: A Prospective, Multicenter Clinical Study Comparing Outcomes of Two Trifocal Toric Intraocular Lens
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.
Read the 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.
- Conditions
- Presbyopia Correction, Astigmatism, Cataract
- Being tested
- Optiflex TRIO Intraocular Lens, AcrySof® IQ PanOptix®
- Medical subject headings
- Astigmatism, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optiflex TRIO Intraocular LensDevice
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®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.
| Study group | Role | What they receive |
|---|---|---|
| Optiflex TRIO (Biotech Europe Meditech Inc. Ltd.) | Experimental | Patients will be implanted with Optiflex TRIO (Biotech Europe Meditech Inc. Ltd.) IOL based on randomization Receives: Device: Optiflex TRIO Intraocular Lens |
| AcrySof® IQ PanOptix® (Alcon Laboratories, Inc.) | Active comparator | Patients will be implanted with AcrySof® IQ PanOptix® (Alcon Laboratories, Inc.) based on randomization Receives: Device: AcrySof® IQ PanOptix® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start22 Nov 2021
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Presbyopia CorrectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotech Healthcare Holding Gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232615
- Sponsor's protocol ID
- BTVCPL-TRITORIC-2019-18
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No