CataractNCT06093880
Observational, Prospective Clinical Investigation on Mini 4 Ready Intraocular Lens
An observational study of Cataract, run by SIFI SpA at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- monofocal intraocular lens
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2024to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Subjects will be deemed eligible for the study if all of the following inclusion criteria are met:
- Older than eighteen years of age at the time of surgery and diagnosed with cataract;
- Unilateral or bilateral cataract removal by phacoemulsification;
- 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.
- In case of bilateral cataract, subject able to underwent second cataract surgery within 1 months from first implant and not before 7 days;
- 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.
Who cannot join
- Subjects participating in a concurrent clinical trial or who have participated in an ophthalmological clinical trial within the last 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational, Non-controlled, Prospective Clinical Investigation to Evaluate Long-term Safety and Performance of Mini 4 Ready Intraocular Lenses in Cataract Patients
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.
Read the 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.
- Conditions
- Cataract
- Being tested
- monofocal intraocular lens
- Keywords
- Monofocal IOL, Monofocal intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monofocal intraocular lensDevice
monofocal aspheric hydrophilic-hydrophobic intraocular lens
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 - 2 years post implant
Secondary outcomes (10)
contrast sensitivity
Evaluation of contrast sensitivity (CS)
Measured: 1 month post implant
posterior capsule opacification (PCO)
Incidence and severity of posterior capsule opacification (PCO)
Measured: 1 and 2 years post implant
posterior capsulotomy
Incidence and severity of posterior capsulotomy
Measured: 1 and 2 years post implant
Monocular and binocular uncorrected (UDVA)
Monocular and binocular uncorrected (UDVA) VA at 4 m under photopic conditions
Measured: 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
Measured: 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
Measured: 1 month, 6 months, 1 year and 2 years
defocus curve
Defocus curve of the implanted eye under photopic conditions
Measured: 1 month
surgical reinterventions
Occurrence of surgical reinterventions for whichever reasons
Measured: 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).
Measured: 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
Measured: 1 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start8 Jan 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SIFI SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093880
- Sponsor's protocol ID
- 054/SI
- Status last verified
- Jul 2025
- First submitted
- 11 Oct 2023
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Non-controlled, Prospective Clinical Investigation to Evaluate Long-term Safety and Performance of Mini 4 Ready Intraocular Lenses in Cataract Patients
- ClinicalTrials.gov ID
- NCT06093880
- Acronym / sponsor ID
- 054/SI
- Conditions
- Cataract
- Keywords
- Monofocal IOL, Monofocal intraocular lens
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- SIFI SpAIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Subjects will be deemed eligible for the study if all of the following inclusion criteria are met:
- Older than eighteen years of age at the time of surgery and diagnosed with cataract;
- Unilateral or bilateral cataract removal by phacoemulsification;
- 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.
- In case of bilateral cataract, subject able to underwent second cataract surgery within 1 months from first implant and not before 7 days;
Key exclusion criteria (1 listed)
- Subjects participating in a concurrent clinical trial or who have participated in an ophthalmological clinical trial within the last 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| monofocal intraocular lensmonofocal aspheric hydrophilic-hydrophobic intraocular lens | Device | – |
Primary outcome
surgical reinterventions and visual acuity (VA) 1-2 years
Time frame: 1 - 2 years post implant
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.
10 secondary outcomes
contrast sensitivity
Time frame: 1 month post implant
posterior capsule opacification (PCO)
Time frame: 1 and 2 years post implant
posterior capsulotomy
Time frame: 1 and 2 years post implant
Monocular and binocular uncorrected (UDVA)
Time frame: 1 and 6 months post implant
Monocular and binocular corrected distance VA (CDVA)
Time frame: 1 and 6 months post implant
manifest refraction
Time frame: 1 month, 6 months, 1 year and 2 years
defocus curve
Time frame: 1 month
surgical reinterventions
Time frame: 6 months
adverse events
Time frame: 6 months
surgical reinterventions and visual acuity (VA) 1 - 6 months
Time frame: 1 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by SIFI SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical reinterventions and visual acuity (VA) 1-2 years (time frame: 1 - 2 years post implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.