Observational Prospective Clinical Investigation on Monofocal Toric Intraocular Lens

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250855
• Other study ID #: 055/SI
• Status: Recruiting
• Start date: April 24, 2024
• Est. completion date: July 2024

Study information

• Verified date: May 2024
• Source: SIFI SpA
• Contact: Daniela Nicolosi
• Phone: 095792218
• Email: daniela.nicolosi[@]sifigroup.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Intervention

Device:
• Mini Toric IOL
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.

Locations

Country	Name	City	State
Romania	Gauss Clinic Bacau	Bacau
Romania	Immunoeye SRL	Sfântu-Gheorghe

Sponsors (1)

Lead Sponsor	Collaborator
SIFI SpA

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of the safety profile: Adverse Events (AEs)	Incidence of Adverse events such as Posterior Capsular Opacification (PCO)	From 12 to 24 months post-surgery
Other	Evaluation of the safety profile	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
Primary	Evaluation of the Visual Performance	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	Evaluation of the Stability	Intraocular Lens (IOL) Rotation Stability	From 12 to 24 months post-surgery