Visual Outcomes of a New Monofocal Intraocular Lens With Modified Optical Profile: a Randomized Controlled Clinical Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- University of Trieste
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Bino DCIVA
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 respectively. The ICB00 IOL is a modified monofocal IOL. Compared to other monofocal IOLs, its modified optical design was created to provide improved intermediate vision, comparable distance vision and a profile of dysphotopsia similar to other monofocal lenses. Considering the modified optical profile of the ICB00 IOL, the primary objective will be the evaluation of visual performance at intermediate distance.
Investigators
Daniele Tognetto
Professor
University of Trieste
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Bino DCIVA
Time Frame: 12 weeks after second eye surgery
Binocular distance corrected intermediate visual acuity
Secondary Outcomes
- Bino UNVA(12 weeks after second eye surgery)
- Bino UIVA(12 weeks after second eye surgery)
- Mono BCDVA(12 weeks after second eye surgery)
- Mono DCIVA(12 weeks after second eye surgery)
- Catquest 9SF score changes(preop and 12 weeks after second eye surgery)
- Binocular defocus curves(12 weeks after second eye surgery)
- Bino BCDVA(12 weeks after second eye surgery)
- Mono UNVA(12 weeks after second eye surgery)
- Bino CNVA(12 weeks after second eye surgery)
- Mono UIVA(12 weeks after second eye surgery)
- Mono UDVA(12 weeks after second eye surgery)
- Bino UDVA(12 weeks after second eye surgery)
- Mono CNVA(12 weeks after second eye surgery)