Status:
COMPLETED
Multicentric Clinical Study on Isatis TF Trifocal Intraocular Lens
Lead Sponsor:
Cutting Edge SAS
Collaborating Sponsors:
targomedGmbH
Conditions:
Cataract
Lens Opacities
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
The study will be a multicentric, prospective open-label ethics committee approved clinical study to investigate safety, visual outcomes, contrast sensitivity and rotational stability after bilateral ...
Detailed Description
This is a staged, multicentric, controlled, prospective, open-label clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of hydrophobic acrylic refracti...
Eligibility Criteria
Inclusion
- Clinically documented age-related cataract in both eyes with no comorbidity;
- Calculated IOL power is within the range of the investigational IOLs;
- Male or female adults ages 50 years or older on the day of screening who have cataracts in both eyes;
- Regular corneal astigmatism (measured by topographer)
- Astigmatism ≤1.0 D (measured by an automatic keratometer)
- Clear intraocular media other than cataract;
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
- Patient is willing to receive bilateral implantation of a trifocal IOL (this inclusion criteria applies only to the study group, not the control group);
- Signed informed consent.
Exclusion
- Age of patient \< 50 years;
- Regular corneal astigmatism \>1.0 dioptres (measured by an automatic keratometer)
- Irregular astigmatism (measured by topographer);
- Difficulty for cooperation (distance from their home, general health conditions);
- Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders);
- Subjects with AMD suspicious eyes as determined by OCT examination;
- Previous intraocular or corneal surgery;
- Traumatic cataract;
- Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;
- Ocular hypertension, suspicious glaucoma or glaucoma;
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);
- Expected complicated surgery;
- Ocular surface disease (clinical symptoms or keratitis);
- Pregnancy or lactation;
- Second eye treatment will only be performed when Best Corrected Distance Visual Acuity (CDVA) of first eye is ≤ 0.2 logMAR (≥ 0.63 decimal);
- Concurrent participation in another drug or device investigation.
- In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued when certain conditions are present at the time of surgery, including:
- zonular instability;
- need for iris manipulation;
- capsular fibrosis or other opacity; and
- inability to fixate IOL in desired position. In such cases, the subject shall be followed until the condition has stabilized.
Key Trial Info
Start Date :
May 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2024
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT04465344
Start Date
May 31 2021
End Date
June 27 2024
Last Update
February 12 2025
Active Locations (7)
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1
Gemini Eye Clinic Ostrava
Ostrava, Czechia, 700 30
2
Gemini Eye Clinic Praha-Krc
Prague, Czechia, 140 00
3
Gemini Eye Clinic Zlín
Zlín, Czechia, 760 01
4
Hospital Donostia
Donostia / San Sebastian, Spain, 20014