NCT07715071

Brief Summary

Randomized clinical trial to evaluate the visual performance of enhanced monofocal and extended depth-of-field intraocular lenses

Trial Health

65
Monitor

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
6mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 21, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 15, 2026

Last Update Submit

July 15, 2026

Conditions

Cataract

Keywords

Intraocular lensCataractEnhanced monfocoal IOLEDoF IOL

Outcome Measures

Primary Outcomes (2)

  • Visual acuity at different distances

    Far vision, intermediate vision, near vision

    1 month, 3 months, 6 months

  • Dysphotopsias

    Dysphotopsias after the IOL implantation

    1 month, 3 months, 6 months

Study Arms (6)

Group 1: Implantation of the Clareon Vivity intraocular lens

EXPERIMENTAL

EDoF IOL

Device: Intraocular lens

Group 2: Implantation of the TECNIS Eyhance intraocular lens

EXPERIMENTAL

Enhanced monofocal IOL

Device: Intraocular lens

Group 3: Implantation of the RayOne EMV intraocular lens

EXPERIMENTAL

Enhanced monofocal IOL

Device: Intraocular lens

Group 4: Implantation of the IsoPure Serenity intraocular lens

EXPERIMENTAL

Enhanced monofocal IOL

Device: Intraocular lens

Group 5: Implantation of the Vivinex Impress intraocular lens

EXPERIMENTAL

Enhanced monofocal IOL

Device: Intraocular lens

Group 6: Implantation of the TECNIS PureSee intraocular lens

EXPERIMENTAL

EDoF IOL

Device: Intraocular lens

Interventions

Intraocular lensDEVICE

Implantation of intraocular lens

Group 1: Implantation of the Clareon Vivity intraocular lensGroup 2: Implantation of the TECNIS Eyhance intraocular lensGroup 3: Implantation of the RayOne EMV intraocular lensGroup 4: Implantation of the IsoPure Serenity intraocular lensGroup 5: Implantation of the Vivinex Impress intraocular lensGroup 6: Implantation of the TECNIS PureSee intraocular lens

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with bilateral cataracts at different stages of development.
  • Patients with functional visual demands.
  • Age between 45 and 80 years.
  • Male or female sex.
  • Ability to provide informed consent.

You may not qualify if:

  • Medical criteria:
  • Corneal astigmatism greater than 1.0 diopter. Pre-existing ocular pathology. Previous refractive surgery. Previous corneal or intraocular implant. Poor general health status or potentially reduced neuroadaptation capacity due to previous stroke, Alzheimer's disease, other forms of dementia, etc.
  • Unrealistic postoperative visual expectations.
  • Intraoperative Withdrawal Criteria
  • Vitreous loss.
  • Pupillary trauma.
  • Factors likely to affect the medium-term performance of the intraocular lens: Zonular damage, Capsulorhexis tear or injury, Capsular rupture, Endothelial damage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Interventions

Lenses, Intraocular

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and SuppliesProstheses and Implants

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2026

First Posted

July 20, 2026

Study Start (Estimated)

September 21, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

July 20, 2026

Record last verified: 2026-07