Status:
COMPLETED
Evaluation of the Extended Depth of Focus After Bilateral Implantation of Hydrophobic IOLs
Lead Sponsor:
Gemini Eye Clinic
Conditions:
Cataract Senile
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
This will be a prospective observational, ethics committee approved study where patients undergoing routine cataract surgery will have bilateral implantation of the intraocular lens (LuxSmart, Bausch ...
Eligibility Criteria
Inclusion
- Cataractous eyes with no comorbidity;
- Calculated IOL power is within the range of the study IOLs;
- Male or female adults ages 50 years or older on the day of screening who have cataract(s) in one or both eyes;
- Regular corneal astigmatism ≤1.5D (measured by an automatic keratometry) in one or both eyes;
- Clear intraocular media other than cataract;
- Dilated pupil size large enough to visualize IOL axis markings postoperatively
- Availability, willingness, skills and cognitive awareness enough to comply with the follow-up/study procedures and study visits.
- Subjects able to read, understand and provide written Informed Consent Form on the Ethics Committee approved Informed Consent Form and provide authorization as appropriate for local privacy regulations.
Exclusion
- Age of patient \<50 years;
- Regular corneal astigmatism \>1.5D (measured by an automatic keratometry) in both eyes;
- Irregular astigmatism;
- Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse;
- Subjects with AMD suspicious eyes as determined by OCT examination;
- Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema;
- Previous intraocular or corneal surgery;
- Traumatic cataract;
- History or presence of macular edema;
- Instability of keratometry or biometry measurements;
- Advanced or decompensated glaucoma;
- Significant dry eye;
Key Trial Info
Start Date :
June 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2021
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04523558
Start Date
June 25 2020
End Date
April 8 2021
Last Update
April 19 2023
Active Locations (1)
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Gemini Eye Clinic
Zlín, Czechia, 760 01