Observational Prospective Clinical Investigation on Monofocal Toric Intraocular Lens

February 20, 2024 updated by: SIFI SpA

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From 12 to 24 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the Stability
Time Frame: From 12 to 24 months post-surgery
Intraocular Lens (IOL) Rotation Stability
From 12 to 24 months post-surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From 12 to 24 months post-surgery
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.
From 12 to 24 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SIFI SpA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 055/SI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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