Outcomes of Bilateral Implantation of an Enhanced Monofocal Intraocular Lens (RCT_ICB00)

Visual Outcomes of a New Monofocal Intraocular Lens With Modified Optical Profile: a Randomized Controlled Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: ICB00 IOL; Device: ZCB00 IOL; Device: CNA0T0 IOL

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Friuli Venezia Giulia
    • Trieste, Friuli Venezia Giulia, Italy, 34100
      • University Eye Clinic of Trieste

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICB00 Group; ICB00 IOL	Device: ICB00 IOL; Bilateral implantation of ICB00 IOL; Other Names: TECNIS EYHANCE IOL
Active Comparator: ZCB00 Group; ZCB00 IOL	Device: ZCB00 IOL; Bilateral implantation of ZCB00 IOL
Active Comparator: CNA0T0 Group; CNA0T0 IOL	Device: CNA0T0 IOL; Bilateral implantation of CNA0T0 IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bino DCIVA	Binocular distance corrected intermediate visual acuity	12 weeks after second eye surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Trieste
• Investigators: Principal Investigator: Daniele Tognetto, MD, University of Trieste

Publications and helpful links

General Publications

• Lundstrom M, Behndig A, Kugelberg M, Montan P, Stenevi U, Pesudovs K. The outcome of cataract surgery measured with the Catquest-9SF. Acta Ophthalmol. 2011 Dec;89(8):718-23. doi: 10.1111/j.1755-3768.2009.01801.x. Epub 2009 Dec 21.
• Ribeiro F, Cochener B, Kohnen T, Mencucci R, Katz G, Lundstrom M, Casanovas AS, Hewlett D. Definition and clinical relevance of the concept of functional vision in cataract surgery ESCRS Position Statement on Intermediate Vision: ESCRS Functional Vision Working Group. J Cataract Refract Surg. 2020 Feb;46 Suppl 1:S1-S3. doi: 10.1097/j.jcrs.0000000000000096. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: cataract surgery; IOL; intermediate distance; enhanced monofocal
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 202_2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes