Status:
COMPLETED
Outcomes of Bilateral Implantation of an Enhanced Monofocal Intraocular Lens
Lead Sponsor:
University of Trieste
Conditions:
Cataract
Eligibility:
All Genders
50-99 years
Phase:
NA
Brief Summary
To evaluate and compare the visual outcomes of an enhanced monofocal intraocular lens (IOL) with two different monofocal IOLs in patients scheduled for bilateral cataract surgery.
Detailed Description
The main objective of the study is the evaluation and comparison of the clinical outcomes of three parallel groups of patients after bilateral implantation of ICB00 IOL or ZCB00 IOL or CNA0T0 IOL resp...
Eligibility Criteria
Inclusion
- clinically significant bilateral cataract (BCVA \<20/40, cataract must be the primary cause of visual impairment)
- axial length between 21 and 27 mm
- the patient must be able to read, understand and provide written informed consent,
- the patient must be willing and able to comply with all study and follow-up procedures
- preoperative refractive cylinder ≤ 0.75 D
Exclusion
- anterior segment pathology that could significantly affect results (e.g., chronic uveitis, iritis, corneal dystrophy, keratoconus)
- diabetic retinopathy
- uncontrolled glaucoma and/or intraocular pressure IOP\> 24 mmHg
- all types of infections (acute eye disease, external/internal infection, systemic infection)
- traumatic cataract
- pupillary abnormalities including aniridia and/or pupil diameter in mesopic conditions in distance vision ≤ 2.5 mm and ≥ 6 mm
- microphthalmia
- amblyopia
- degenerative visual disorders (for example macular degeneration, optic nerve atrophy or retinal disorders)
- previous intraocular and corneal surgery
- systemic or ocular pharmacotherapy, which may impact visual acuity and/or cause floppy iris syndrome and/or insufficient dilation in the opinion of the investigator
- patients who are unable to fixate for a prolonged time (e.g. strabismus, nystagmus)
- period of pregnancy or breastfeeding for female patients
Key Trial Info
Start Date :
November 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06118944
Start Date
November 11 2019
End Date
January 31 2023
Last Update
November 7 2023
Active Locations (1)
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1
University Eye Clinic of Trieste
Trieste, Friuli Venezia Giulia, Italy, 34100