Clinical trial NCT06093880: Observational, Prospective Clinical Investigation on Mini 4 Ready Intraocular Lens
Official title: Observational, Non-controlled, Prospective Clinical Investigation to Evaluate Long-term Safety and Performance of Mini 4 Ready Intraocular Lenses in Cataract Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cataract
Keywords: Monofocal IOL
Monofocal intraocular lens
Lead sponsor: SIFI SpA
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target population comprise men and women aged ≥18 years requiring unilateral or bilateral cataract surgery and who are eligible for a monofocal IOL. The source population comprise patients scheduled to receive the Mini 4 Ready IOL in whom the cataractous lens could be removed by phacoemulsification following circular capsulorhexis, leaving the posterior capsule intact.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: surgical reinterventions and visual acuity (VA) 1-2 years
timeFrame: 1 - 2 years post implant
Secondary outcomes:
measure: contrast sensitivity
timeFrame: 1 month post implant
measure: posterior capsule opacification (PCO)
timeFrame: 1 and 2 years post implant
measure: posterior capsulotomy
timeFrame: 1 and 2 years post implant
measure: Monocular and binocular uncorrected (UDVA)
timeFrame: 1 and 6 months post implant
measure: Monocular and binocular corrected distance VA (CDVA)
timeFrame: 1 and 6 months post implant
measure: manifest refraction
timeFrame: 1 month, 6 months, 1 year and 2 years
measure: defocus curve
timeFrame: 1 month
measure: surgical reinterventions
timeFrame: 6 months
measure: adverse events
timeFrame: 6 months
measure: surgical reinterventions and visual acuity (VA) 1 - 6 months
timeFrame: 1 and 6 months
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Daniela Nicolosi
Study officials:
References: