Observational, Prospective Clinical Investigation on Mini 4 Ready Intraocular Lens

Cataract Clinical Trial

Official title:

Observational, Non-controlled, Prospective Clinical Investigation to Evaluate Long-term Safety and Performance of Mini 4 Ready Intraocular Lenses in Cataract Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06093880
• Other study ID #: 054/SI
• Status: Recruiting
• Start date: January 8, 2024
• Est. completion date: June 2026

Study information

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

Clinical Trial Summary

Cataract surgery presents an extremely high success rate in improving vision and quality of life and it is currently the most commonly performed ophthalmic surgery, especially considering its growing utility in the aging population (e.g., more than 20 million worldwide underwent the procedure in 2015); it is possible to affirm that benefits clearly outweigh risks.

However, although cataract surgery is highly effective and relatively safe, owing to the enormous numbers, even uncommon surgical complications could potentially harm the patients. For this reason, it is essential to continue to consider the possible risks and undesirable side-effects associated to cataract surgery, such as post-cataract endophthalmitis (POE), postcataract opacification (PCO), PCME, dysphotopsias, retinal detachment, and IOL dislocation.

Description:

This is an observational, non-controlled, prospective clinical investigation to evaluate long-term safety and performance of Mini 4 Ready Intraocular Lenses in cataract patients.

Specifically the aim of the investigation is to evaluate:

• Accumulated incidence of surgical reinterventions and of achievement of visual acuity (VA) of 0.3 logMAR units or better after 1 and 2 years following IOL implant;

• Evaluation of contrast sensitivity (CS) after 1 month following IOL implant.

• Incidence and severity of posterior capsule opacification (PCO) and incidence of posterior capsulotomy after 1 and 2 years following IOL eye implant.

• Monocular and binocular uncorrected (UDVA) and corrected (CDVA)distance VA at 4 m under photopic conditions at 1 and 6 months.

• Overall refractive power, measured as manifest (subjective) and subjective refraction, standard and converted to spherical equivalent refraction at 1 and 6 months and at 1 and 2 years.

• Defocus curve of the implanted eye under photopic conditions at 1 month.

• Occurrence of surgical reinterventions for whichever reason.

• Occurrence of any adverse untoward outcome, including any adverse event (such as, but not limited to, pseudophakic cystoid macular edema (PCME), retinal detachment, signs of inflammation, surgical site infections (SSI), pupillary block, and IOL tilt and decentration).

• Accumulated incidence of surgical reinterventions and of achievement of visual acuity (VA) of 0.3 logMAR units or better after 1- and 6-months following index eye implant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: June 2026
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects will be deemed eligible for the study if all of the following inclusion criteria are met:

1. Older than eighteen years of age at the time of surgery and diagnosed with cataract;

2. Unilateral or bilateral cataract removal by phacoemulsification;

3. Correction of resulting aphakia with the Mini 4 Ready IOL. Indication for use of the Mini 4 Ready should be previous to and not conditioned by study participation.

4. In case of bilateral cataract, subject able to underwent second cataract surgery within 1 months from first implant and not before 7 days;

5. Willing and able to complete all required postoperative visits;

6. 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 who have participated in an ophthalmological clinical trial within the last 30 days.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• monofocal intraocular lens
monofocal aspheric hydrophilic-hydrophobic intraocular lens

Locations

Country	Name	City	State
Italy	Daniela Nicolosi	Catania

Sponsors (1)

Lead Sponsor	Collaborator
SIFI SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical reinterventions and visual acuity (VA) 1-2 years	Long-time accumulated incidence of surgical reinterventions and of achievement of visual acuity (VA) of 0.3 logMAR units or better after 1 and 2 years following IOL implant.	1 - 2 years post implant
Secondary	contrast sensitivity	Evaluation of contrast sensitivity (CS)	1 month post implant
Secondary	posterior capsule opacification (PCO)	Incidence and severity of posterior capsule opacification (PCO)	1 and 2 years post implant
Secondary	posterior capsulotomy	Incidence and severity of posterior capsulotomy	1 and 2 years post implant
Secondary	Monocular and binocular uncorrected (UDVA)	Monocular and binocular uncorrected (UDVA) VA at 4 m under photopic conditions	1 and 6 months post implant
Secondary	Monocular and binocular corrected distance VA (CDVA)	Monocular and binocular corrected distance VA (CDVA) at 4 m under photopic conditions	1 and 6 months post implant
Secondary	manifest refraction	Overall refractive power, measured as manifest objective and subjective refraction, standard and converted to spherical equivalent refraction	1 month, 6 months, 1 year and 2 years
Secondary	defocus curve	Defocus curve of the implanted eye under photopic conditions	1 month
Secondary	surgical reinterventions	Occurrence of surgical reinterventions for whichever reasons	6 months
Secondary	adverse events	Occurrence of any adverse untoward outcome, including any adverse event (such as, but not limited to, pseudophakic cystoid macular edema (PCME), retinal detachment, signs of inflammation, surgical site infections (SSI), pupillary block, and IOL tilt and decentration).	6 months
Secondary	surgical reinterventions and visual acuity (VA) 1 - 6 months	Short-time accumulated incidence of surgical reinterventions and of achievement of visual acuity (VA) of 0.3 logMAR units or better	1 and 6 months