CataractNCT06250855
Observational Prospective Clinical Investigation on Monofocal Toric Intraocular Lens
An observational study of Cataract and Astigmatism, run by SIFI SpA at 2 sites in Romania.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cataract, Astigmatism
- What is being tested?
- Mini Toric IOL
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 105 participants
- Where
- 2 sitesRomania
- Study dates
- 24 Apr 2024to 27 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (males and females) ≥18 years with cataract and pre-existing corneal astigmatism who have undergone monocular or binocular Mini Toric Ready implantation. Subjects enrolled in the investigation underwent cataract surgery in which the cataract lens was removed by phacoemulsification, with circular capsulorhexis, leaving the posterior capsule intact.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Romania2 sites
Gauss Clinic Bacau
Bacau, 600269
Immunoeye SRL
Sfantu Gheorghe, 520024
About this study
Official title: At Least One-year Long-term Clinical Outcomes Following Monofocal Toric Intraocular Lens Implantation: Observational Prospective Clinical Investigation
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.
Read the detailed 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.
- Conditions
- Cataract, Astigmatism
- Being tested
- Mini Toric IOL
- Keywords
- Cataract, Astigmatism, Monofocal IOL, Toric IOL
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini Toric IOLDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 12 to 24 months post-surgery
Secondary outcomes (1)
Evaluation of the Stability
Intraocular Lens (IOL) Rotation Stability
Measured: From 12 to 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start24 Apr 2024
- Primary completion27 Oct 2024
- Study completion27 Oct 2024
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- SIFI SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250855
- Sponsor's protocol ID
- 055/SI
- Status last verified
- Dec 2025
- First submitted
- 1 Feb 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At Least One-year Long-term Clinical Outcomes Following Monofocal Toric Intraocular Lens Implantation: Observational Prospective Clinical Investigation
- ClinicalTrials.gov ID
- NCT06250855
- Acronym / sponsor ID
- 055/SI
- Conditions
- Cataract, Astigmatism
- Keywords
- Cataract, Astigmatism, Monofocal IOL, Toric IOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- SIFI SpAIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 27 Oct 2024 (actual)
- Study completion
- 27 Oct 2024 (actual)
- First posted
- 9 Feb 2024 (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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (males and females) ≥18 years with cataract and pre-existing corneal astigmatism who have undergone monocular or binocular Mini Toric Ready implantation. Subjects enrolled in the investigation underwent cataract surgery in which the cataract lens was removed by phacoemulsification, with circular capsulorhexis, leaving the posterior capsule intact.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Mini Toric IOLAdults (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. | Device | – |
Primary outcome
Evaluation of the Visual Performance
Time frame: From 12 to 24 months post-surgery
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.
1 secondary outcome
Evaluation of the Stability
Time frame: From 12 to 24 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Astigmatism, run by SIFI SpA at 2 sites in Romania.
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 6 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: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of the Visual Performance (time frame: From 12 to 24 months post-surgery). 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 Dec 2025.