Cataract
Conditions
Keywords
IOL, intermediate distance, cataract surgery, enhanced monofocal
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.
Interventions
DEVICEICB00 IOL
Bilateral implantation of ICB00 IOL
DEVICEZCB00 IOL
Bilateral implantation of ZCB00 IOL
DEVICECNA0T0 IOL
Bilateral implantation of CNA0T0 IOL
Sponsors
University of Trieste
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 99 Years
Healthy volunteers
No
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bino DCIVA | 12 weeks after second eye surgery | Binocular distance corrected intermediate visual acuity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mono UIVA | 12 weeks after second eye surgery | Monocular uncorrected intermediate visual acuity |
| Bino UIVA | 12 weeks after second eye surgery | Binocular uncorrected intermediate visual acuity |
| Mono UDVA | 12 weeks after second eye surgery | Monocular uncorrected distance visual acuity |
| Bino UDVA | 12 weeks after second eye surgery | Binocular uncorrected distance visual acuity |
| Mono BCDVA | 12 weeks after second eye surgery | Monocular best corrected distance visual acuity |
| Bino BCDVA | 12 weeks after second eye surgery | Binocular best corrected distance visual acuity |
| Mono DCIVA | 12 weeks after second eye surgery | Monocular distance corrected intermediate visual acuity |
| Bino UNVA | 12 weeks after second eye surgery | Binocular uncorrected near visual acuity |
| Mono CNVA | 12 weeks after second eye surgery | Monocular corrected near visual acuity |
| Bino CNVA | 12 weeks after second eye surgery | Binocular corrected near visual acuity |
| Binocular defocus curves | 12 weeks after second eye surgery | Binocular defocus curves in photopic conditions (from -4 D up to +2.00 D) |
| Catquest 9SF score changes | preop and 12 weeks after second eye surgery | Changes in Catquest 9SF score before and 3 months after surgery |
| Mono UNVA | 12 weeks after second eye surgery | Monocular uncorrected near visual acuity |
Countries
Italy
Outcome results
None listed