An observational study in Cataract, sponsored by SIFI SpA. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by SIFI SpA · Observational
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Among 28 studies in Cataract with a site in Italy — none open to participants now, 1 under way, none of them phase 3. Cataract · Italy.
Among the 28 studies in Cataract with a site in Italy, this one is the 3rd largest by planned enrollment of the 11 observational ones that give a count, is one of 2 that started in 2024, is one of 11 observational ones, and was the 22nd registered.
1,631 studies on the registry are indexed under Cataract; 235 are open to participants now.
Browse Cataract studies →None of the 28 studies in Cataract with a site in Italy is open now. The open studies under Cataract, anywhere →
Of the 142 Cataract studies recruiting now, 88 (62%) set no upper age limit and 8 (6%) stop at 75 or younger; 10 take children under 18; 16 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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28 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 2 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 125 is above the median of 89 across 475 observational studies indexed under Cataract.
Median enrollment 121 across the 17 interventional studies, 100 across the 11 observational. Of the 25 that completed or were terminated, 7 (28%) have results posted.
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15 of 28 have an industry lead sponsor. The 10 most frequent:
SIFI SpA is the lead sponsor of 19 studies on the registry; none are open to participants now.
SIFI SpA has 9 studies filed under Cataract — fewer than ten, so there is no comparison to draw.
1 of the studies in Cataract with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06093880SIFI SpAObservational, Prospective Clinical Investigation on Mini 4 Ready Intraocular Lens | 2027-07 |
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Among the 28 studies in Cataract with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects will be deemed eligible for the study if all of the following inclusion criteria are met:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
monofocal aspheric hydrophilic-hydrophobic intraocular lens
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.
Time frame: 1 - 2 years post implant
contrast sensitivity
Evaluation of contrast sensitivity (CS)
Time frame: 1 month post implant
posterior capsule opacification (PCO)
Incidence and severity of posterior capsule opacification (PCO)
Time frame: 1 and 2 years post implant
posterior capsulotomy
Incidence and severity of posterior capsulotomy
Time frame: 1 and 2 years post implant
Monocular and binocular uncorrected (UDVA)
Monocular and binocular uncorrected (UDVA) VA at 4 m under photopic conditions
Time frame: 1 and 6 months post implant
Monocular and binocular corrected distance VA (CDVA)
Monocular and binocular corrected distance VA (CDVA) at 4 m under photopic conditions
Time frame: 1 and 6 months post implant
manifest refraction
Overall refractive power, measured as manifest objective and subjective refraction, standard and converted to spherical equivalent refraction
Time frame: 1 month, 6 months, 1 year and 2 years
defocus curve
Defocus curve of the implanted eye under photopic conditions
Time frame: 1 month
surgical reinterventions
Occurrence of surgical reinterventions for whichever reasons
Time frame: 6 months
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).
Time frame: 6 months
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
Time frame: 1 and 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Jul 2027, 42 months after the start.
Of 67 industry-sponsored observational studies under Cataract, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's planned 42 months is above that.
Counting every sponsor, half of 234 studies reached it within 16 months; a quarter within 9 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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SIFI SpA