A prospective, multicenter clinical study comparing outcomes of two trifocal toric intraocular lens

A prospective, multicenter clinical study comparing outcomes of two trifocal toric intraocular lens - BTVCPL-TRITORIC-2019-18

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025969

Enrollment

Registered

2021-08-04

Start date

2021-09-29

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

h25

Interventions

Group 1: 42 patients (84 eyes) will be implanted with Optiflex TRIO Trifocal Toric intraocular lens Group 2: 42 patients (84 eyes) will be implanted with AcrySof® IQ PanOptix® Trifocal Toric intraocul

Eligibility

Sex/Gender

All

Age

21 Years to No maximum

Inclusion criteria

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

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
The primary effectiveness endpoint is binocular distance corrected intermediate visual acuity (BCIDVA) at 70 cms at 6 months post-operative, with a target of equivalency between the two IOLs.	—

Secondary

Measure	Time frame
Adverse Events: Cumulative and persistent rates of adverse events in first operative eyes in comparison to ISO 11979-7:2018 SPE historical control grid rates. Success criteria for each type of event will be a rate not statistically greater than the control rate. a) Cystoid macular oedema b) Hypopyon c) Endophthalmitis d) Lens dislocation e) Pupillary Block f) Retinal Detachment g) Secondary Surgical intervention h) Corneal stroma oedema i) Raised IOP requiring treatment	—

Measure

Time frame

Adverse Events: Cumulative and persistent rates of adverse events in first operative eyes in comparison to ISO 11979-7:2018 SPE historical control grid rates. Success criteria for each type of event will be a rate not statistically greater than the control rate. a) Cystoid macular oedema b) Hypopyon c) Endophthalmitis d) Lens dislocation e) Pupillary Block f) Retinal Detachment g) Secondary Surgical intervention h) Corneal stroma oedema i) Raised IOP requiring treatment

—

Countries

Germany, India

Contacts

Public ContactBasak Deveci Summer

BIOTECH HEALTHCARE HOLDING GMBH

basak.deveci@biotechhealthcare.com+90 551 219 36 06

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026