NCT06118944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
Last Updated

November 7, 2023

Status Verified

October 1, 2023

Enrollment Period

2.9 years

First QC Date

October 31, 2023

Last Update Submit

October 31, 2023

Conditions

Cataract

Keywords

IOLintermediate distancecataract surgeryenhanced monofocal

Outcome Measures

Primary Outcomes (1)

  • Bino DCIVA

    Binocular distance corrected intermediate visual acuity

    12 weeks after second eye surgery

Secondary Outcomes (13)

  • Mono DCIVA

    12 weeks after second eye surgery

  • Mono UIVA

    12 weeks after second eye surgery

  • Bino UIVA

    12 weeks after second eye surgery

  • Mono UDVA

    12 weeks after second eye surgery

  • Bino UDVA

    12 weeks after second eye surgery

  • +8 more secondary outcomes

Study Arms (3)

ICB00 Group

EXPERIMENTAL

ICB00 IOL

Device: ICB00 IOL

ZCB00 Group

ACTIVE COMPARATOR

ZCB00 IOL

Device: ZCB00 IOL

CNA0T0 Group

ACTIVE COMPARATOR

CNA0T0 IOL

Device: CNA0T0 IOL

Interventions

ICB00 IOLDEVICE

Bilateral implantation of ICB00 IOL

Also known as: TECNIS EYHANCE IOL
ICB00 Group
ZCB00 IOLDEVICE

Bilateral implantation of ZCB00 IOL

ZCB00 Group
CNA0T0 IOLDEVICE

Bilateral implantation of CNA0T0 IOL

CNA0T0 Group

Eligibility Criteria

Age50 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Clinic of Trieste

Trieste, Friuli Venezia Giulia, 34100, Italy

Location

Related 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.

    PMID: 20039853BACKGROUND

  • 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.

    PMID: 32126025BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Daniele Tognetto, MD

    University of Trieste

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 7, 2023

Study Start

November 11, 2019

Primary Completion

September 30, 2022

Study Completion

January 31, 2023

Last Updated

November 7, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)