NCT07276217

Brief Summary

The aim of the study is to create a patient registry that will allow for comparison of cataract treatment outcomes using phacoemulsification with implantation of different types of intraocular lenses.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
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

Study Progress90%
Jan 2025Jul 2026

Study Start

First participant enrolled

January 2, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 10, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

December 10, 2025

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

November 28, 2025

Last Update Submit

November 28, 2025

Conditions

CataractIntraocular Lens

Keywords

cataractintraocular lensphacoemulsification

Outcome Measures

Primary Outcomes (1)

  • Corrected and Uncorrected Distance, Intermediate and Near Visual Acuity

    Distance, intermediate, and near visual acuity will be measured both uncorrected and corrected using standard ETDRS charts at 4 meters for distance, 66 cm for intermediate, and 40 cm for near visual acuity.

    Measured at the follow-up visit up to 60 months after cataract surgery

Secondary Outcomes (12)

  • Objective Refraction

    Measured at the follow-up visit up to 60 months after cataract surgery

  • Subjective Refraction

    Measured at the follow-up visit up to 60 months after cataract surgery

  • Monocular and Binocular Defocus Curve

    Measured at the follow-up visit up to 60 months after cataract surgery

  • Contrast Sensitivity

    Measured at the follow-up visit up to 60 months after cataract surgery

  • Keratometry

    Measured at the follow-up visit up to 60 months after cataract surgery

  • +7 more secondary outcomes

Study Arms (3)

Bilateral Monofocal IOL

Patients who underwent bilateral cataract surgery with implantation of monofocal intraocular lenses in both eyes between 2021 and 2025, and attended a follow-up visit.

Device: Intraocular lens

Bilateral Monofocal-plus IOL

Patients who underwent bilateral cataract surgery with implantation of monofocal-plus intraocular lenses in both eyes between 2021 and 2025, and attended a follow-up visit.

Device: Intraocular lens

Bilateral EDOF IOL

Patients who underwent bilateral cataract surgery with implantation of extended-depth-of-focus (EDOF) intraocular lenses in both eyes between 2021 and 2025, and attended a follow-up visit.

Device: Intraocular lens

Interventions

Intraocular lensDEVICE

Implantation of an intraocular lens following phacoemulsification cataract extraction, with lens type selected according to routine clinical practice (e.g., monofocal, toric, multifocal, or extended-depth-of-focus).

Bilateral EDOF IOLBilateral Monofocal IOLBilateral Monofocal-plus IOL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have undergone or are scheduled for bilateral cataract surgery at Sensor Cliniq between 2021 and 2025.

You may qualify if:

  • Patients who have undergone cataract surgery or are scheduled for bilateral cataract surgery with implantation of an extended-depth-of-focus (EDOF) intraocular lens, a monofocal-plus intraocular lens, or a standard monofocal intraocular lens.

You may not qualify if:

  • Anterior or posterior segment pathologies affecting postoperative visual acuity, including but not limited to: severe dry eye syndrome, corneal dystrophies, uveitis, retinal degenerative changes, glaucoma, or diabetic retinopathy.
  • Pseudoexfoliation syndrome
  • Keratoconus
  • History of laser refractive surgery
  • Prior ocular surgery other than cataract surgery
  • Amblyopia
  • Posterior capsule opacification
  • Postoperative best-corrected visual acuity (BCVA) less 0.5
  • Intraoperative complications, including posterior capsule rupture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sensor Cliniq

Warsaw, Poland

RECRUITING

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
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
60 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmologist, Medical Doctor

Study Record Dates

First Submitted

November 28, 2025

First Posted

December 10, 2025

Study Start

January 2, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

December 10, 2025

Record last verified: 2025-11

Locations

PL(1)