Comparing two trifocal toric intraocular lenses for cataract surgery.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Internationale Innovative Ophthalmochirurgie GbR
  Düsseldorf, North Rhine-Westphalia, Germany Recruiting
• Augentagesklinik
  Greven, North Rhine-Westphalia, Germany Recruiting
• Augentagesklinik
  Rheine, North Rhine-Westphalia, Germany Recruiting
• Dr. Agarwal Eye Hospital
  Chennai, Tamil Nadu, India Recruiting
• Hospital Arruzafa
  Córdoba, Córdoba, Spain Recruiting
• Netradhama Superspeciality Eye Hospital
  Bangalore, Karnatak, India Not yet recruiting

Study contacts

• Study coordinator: BHARGAV D JOSHI, M.Sc.
• Email: bhargav.joshi@biotechhealthcare.com
• Phone: +917966823000

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.