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Completed

NCT Number: NCT06118944

Outcomes of Bilateral Implantation of an Enhanced Monofocal Intraocular Lens

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Eye Clinic of Trieste

Trieste, Friuli Venezia Giulia, 34100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICB00 IOL

Device

Bilateral implantation of ICB00 IOL

Other names: TECNIS EYHANCE IOL

ZCB00 IOL

Device

Bilateral implantation of ZCB00 IOL

CNA0T0 IOL

Device

Bilateral implantation of CNA0T0 IOL

Primary outcomes

  1. Bino DCIVA

    Time frame: 12 weeks after second eye surgery

    Binocular distance corrected intermediate visual acuity

Secondary outcomes

  1. Mono DCIVA

    Time frame: 12 weeks after second eye surgery

    Monocular distance corrected intermediate visual acuity

  2. Mono UIVA

    Time frame: 12 weeks after second eye surgery

    Monocular uncorrected intermediate visual acuity

  3. Bino UIVA

    Time frame: 12 weeks after second eye surgery

    Binocular uncorrected intermediate visual acuity

  4. Mono UDVA

    Time frame: 12 weeks after second eye surgery

    Monocular uncorrected distance visual acuity

  5. Bino UDVA

    Time frame: 12 weeks after second eye surgery

    Binocular uncorrected distance visual acuity

  6. Mono BCDVA

    Time frame: 12 weeks after second eye surgery

    Monocular best corrected distance visual acuity

  7. Bino BCDVA

    Time frame: 12 weeks after second eye surgery

    Binocular best corrected distance visual acuity

  8. Mono UNVA

    Time frame: 12 weeks after second eye surgery

    Monocular uncorrected near visual acuity

  9. Bino UNVA

    Time frame: 12 weeks after second eye surgery

    Binocular uncorrected near visual acuity

  10. Mono CNVA

    Time frame: 12 weeks after second eye surgery

    Monocular corrected near visual acuity

  11. Bino CNVA

    Time frame: 12 weeks after second eye surgery

    Binocular corrected near visual acuity

  12. Binocular defocus curves

    Time frame: 12 weeks after second eye surgery

    Binocular defocus curves in photopic conditions (from -4 D up to +2.00 D)

  13. Catquest 9SF score changes

    Time frame: preop and 12 weeks after second eye surgery

    Changes in Catquest 9SF score before and 3 months after surgery

Sponsors and collaborators

Lead sponsor

University of Trieste

Other

Registry information

Official study title

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

Acronym: RCT_ICB00

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Nov 7, 2023
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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