Outcomes of Bilateral Implantation of an Enhanced Monofocal Intraocular Lens

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: CNA0T0 IOL; Device: ICB00 IOL; Device: ZCB00 IOL

• Registration Number: NCT06118944
• Lead Sponsor: University of Trieste

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.

Study Timeline

• Study Start: 2019-11-11
• Primary Completion: 2022-09-30
• Study Completion: 2023-01-31
• Status Verified: 2023-10
• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-10-31
• Last Update Submitted: 2023-10-31
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CNA0T0 Group	CNA0T0 IOL	CNA0T0 IOL
ICB00 Group	ICB00 IOL	ICB00 IOL
ZCB00 Group	ZCB00 IOL	ZCB00 IOL

Primary Outcome Measures

Name	Time	Method
Bino DCIVA	12 weeks after second eye surgery	Binocular distance corrected intermediate visual acuity

Secondary Outcome Measures

Name	Time	Method
Bino UNVA	12 weeks after second eye surgery	Binocular uncorrected near visual acuity
Bino UIVA	12 weeks after second eye surgery	Binocular uncorrected intermediate visual acuity
Mono BCDVA	12 weeks after second eye surgery	Monocular best corrected distance visual acuity
Mono DCIVA	12 weeks after second eye surgery	Monocular distance corrected intermediate visual acuity
Catquest 9SF score changes	preop and 12 weeks after second eye surgery	Changes in Catquest 9SF score before and 3 months after surgery
Binocular defocus curves	12 weeks after second eye surgery	Binocular defocus curves in photopic conditions (from -4 D up to +2.00 D)
Bino BCDVA	12 weeks after second eye surgery	Binocular best corrected distance visual acuity
Mono UNVA	12 weeks after second eye surgery	Monocular uncorrected near visual acuity
Bino CNVA	12 weeks after second eye surgery	Binocular corrected near visual acuity
Mono UIVA	12 weeks after second eye surgery	Monocular 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 CNVA	12 weeks after second eye surgery	Monocular corrected near visual acuity

Trial Locations

Locations (1)

University Eye Clinic of Trieste; 🇮🇹 Trieste, Friuli Venezia Giulia, Italy