Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06250855
Other study ID # 055/SI
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04685538 - Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification. Phase 3
Recruiting NCT06060041 - IC-8 Apthera IOL New Enrollment Post Approval Study
Recruiting NCT05518539 - Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens
Recruiting NCT05271942 - Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods N/A
Active, not recruiting NCT04778501 - PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia N/A
Completed NCT05062564 - Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye N/A
Completed NCT03751033 - Influence of DisCoVisc Ophthalmic Viscosurgical Device (OVD) on Intraoperative Aberrometry Readings N/A
Completed NCT02529488 - Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00 N/A
Completed NCT04539548 - A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract Phase 3
Completed NCT03740659 - Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery Phase 2
Completed NCT03494257 - Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification N/A
Completed NCT05119127 - Rotational Stability of Acrysof IQ Vivity Extended Vision Toric IOL and Refractive Visual Outcome. N/A
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Completed NCT03739528 - Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery Phase 3
Completed NCT02888210 - A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery Phase 3
Completed NCT03356847 - Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery N/A
Completed NCT04332640 - Clinical Evaluation of the Next Generation Phaco System N/A
Recruiting NCT03638726 - Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification Phase 4
Completed NCT03050697 - Evaluation of the Safety and Performance of the HARMONI® Toric Lens N/A