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Completed

NCT Number: NCT06250855

Observational Prospective Clinical Investigation on Monofocal Toric Intraocular Lens

Evaluation, at least one-year long-term, of the clinical performance and safety of Mini Toric Ready Intraocular Lens (IOL), a monofocal toric intraocular lens.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gauss Clinic Bacau, Bacau, Romania

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About this study

Observational prospective clinical investigation based on the medical records of patients who undergone uncomplicated cataract surgery with implantation of Mini Toric Ready IOL and on a clinical visit after at least one year from the surgery. Eyes with corneal astigmatism ≥0.75 diopters were included. Postoperative evaluations included monocular or binocular uncorrected and corrected distance visual acuity; contrast sensitivity measured after at least one-year postoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eighteen years of age or older at the time of surgery and diagnosed with unilateral or bilateral cataracts;
  • Preoperative total corneal astigmatism ≥0.75D;
  • Unilateral or bilateral cataract removal by phacoemulsification;
  • Clear intraocular media other than cataract;
  • Willing and able to complete all required postoperative visits;
  • Able to comprehend and sign a statement of informed consent consistent with local regulation for research in human subjects.

Exclusion criteria

  • Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days before the surgery.

Treatment and study plan

Mini Toric IOL

Device

Adults (males and females) ≥18 years with cataract and pre-existing corneal astigmatism who have undergone monocular or binocular Mini Toric Ready implantation after cataract surgery in which the cataract lens was removed by phacoemulsification, with circular capsulorhexis, leaving the posterior capsule intact.

Primary outcomes

  1. Evaluation of the Visual Performance

    Time frame: From 12 to 24 months post-surgery

    Evaluate Mini Toric Ready Intraocular Lens (IOL) performance in terms of correction of spherical and cylindrical visual defects, corrected and uncorrected monocular and/or binocular distance visual acuity at least 12 months post implant.

Secondary outcomes

  1. Evaluation of the Stability

    Time frame: From 12 to 24 months post-surgery

    Intraocular Lens (IOL) Rotation Stability

Other outcomes

  1. Evaluation of the safety profile: Adverse Events (AEs)

    Time frame: From 12 to 24 months post-surgery

    Incidence of Adverse events such as Posterior Capsular Opacification (PCO)

  2. Evaluation of the safety profile

    Time frame: From 12 to 24 months post-surgery

    Rate of secondary surgical interventions (SSIs) related to the optical properties of the IOL after at least 12 months post implant.

Sponsors and collaborators

Lead sponsor

SIFI SpA

Industry

Registry information

Official study title

At Least One-year Long-term Clinical Outcomes Following Monofocal Toric Intraocular Lens Implantation: Observational Prospective Clinical Investigation

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2024
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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