Comparing two trifocal toric intraocular lenses for cataract surgery.

A Prospective, Multicenter Clinical Study Comparing Outcomes of Two Trifocal Toric Intraocular Lens

This trial will test two different trifocal toric intraocular lenses to see which gives better intermediate-distance vision and satisfaction for adults with cataracts and regular corneal astigmatism.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 138 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Biotech Healthcare Holding Gmbh (Industry-sponsored)
• Locations: 6 sites (Düsseldorf, North Rhine-Westphalia and 5 other locations)
• Trial ID: NCT07232615 on ClinicalTrials.gov

What this trial studies

This multi‑site interventional comparison enrolls adults having cataract surgery with regular corneal astigmatism who receive one of two commercially available trifocal toric intraocular lenses (Optiflex TRIO or AcrySof IQ PanOptix). The primary outcome is distance‑corrected intermediate visual acuity, with secondary outcomes including safety measures and patient‑reported satisfaction. Eyes will be evaluated preoperatively and at scheduled postoperative visits to measure visual acuity, refractive outcomes, and adverse events. The trial is conducted at three ophthalmology centers in North Rhine‑Westphalia, Germany.

Who should consider this trial

Good fit: Adults over 21 with cataract and regular corneal astigmatism between 0.75 and 4.5 D, whose calculated IOL power fits the investigational lenses and who can consent and comply with follow‑up are ideal candidates.

Not a fit: Patients with prior intraocular or corneal surgery, irregular astigmatism, active ocular disease in the operative eye, certain systemic conditions, pregnancy or lactation, or those outside the specified astigmatism range are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could help patients achieve better intermediate and overall vision after cataract surgery and reduce dependence on glasses.

How similar studies have performed: Similar trifocal and toric trifocal lenses, including AcrySof PanOptix variations, have shown improved spectacle independence and good visual outcomes in prior published studies.

Eligibility 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:

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

Where this trial is running

Düsseldorf, North Rhine-Westphalia and 5 other locations

• Internationale Innovative Ophthalmochirurgie GbR — Düsseldorf, North Rhine-Westphalia, Germany (Recruiting)
• Augentagesklinik — Greven, North Rhine-Westphalia, Germany (Recruiting)
• Augentagesklinik — Rheine, North Rhine-Westphalia, Germany (Recruiting)
• Netradhama Superspeciality Eye Hospital — Bangalore, Karnatak, India (Not_yet_recruiting)
• Dr. Agarwal Eye Hospital — Chennai, Tamil Nadu, India (Recruiting)
• Hospital Arruzafa — Córdoba, Córdoba, Spain (Recruiting)

Study contacts

• Study coordinator: BHARGAV D JOSHI, M.Sc.

Conditions Presbyopia Correction; Astigmatism; Cataract