Outcomes of Bilateral Implantation of an Enhanced Monofocal Intraocular Lens

Cataract Clinical Trial

— RCT_ICB00  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06118944
• Other study ID #: 202_2019
• Status: Completed
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: January 31, 2023

Study information

• Verified date: October 2023
• Source: University of Trieste
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 31, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• ICB00 IOL
Bilateral implantation of ICB00 IOL
• ZCB00 IOL
Bilateral implantation of ZCB00 IOL
• CNA0T0 IOL
Bilateral implantation of CNA0T0 IOL

Locations

Country	Name	City	State
Italy	University Eye Clinic of Trieste	Trieste	Friuli Venezia Giulia

Sponsors (1)

Lead Sponsor	Collaborator
University of Trieste

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

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