Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07092020

Extended Depth of Focus (EDF) Intraocular Lens (IOL) Versus Monofocal Intracoular Lens (IOL)

Led by Carl Zeiss Meditec AG · Updated on 2026-03-12

220

Participants Needed

14

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Extended depth of focus (EDF) intraocular lens (IOL) versus Monofocal intraocular lens (IOL)

CONDITIONS

Official Title

Extended Depth of Focus (EDF) Intraocular Lens (IOL) Versus Monofocal Intracoular Lens (IOL)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients of any gender aged 18 years or older
  • Clinically significant bilateral age-related cataracts planned for phacoemulsification cataract extraction and eligible for posterior chamber intraocular lens implantation
  • Preoperative corneal astigmatism of 1.00 diopter or less
  • Calculated lens power within the available range
  • Clear intraocular media other than cataract
  • Willing and able to provide informed consent
  • Willing and able to comply with study visits and procedures
Not Eligible

You will not qualify if you...

  • Preoperative corrected distance visual acuity better than 0.3 logMAR (0.5 decimal)
  • Endothelial cell count less than 2000/mm2
  • Acute, chronic, or uncontrolled systemic disease increasing operative risk or confounding outcomes
  • Ocular conditions that may cause visual acuity of 0.2 logMAR or worse during the study
  • Clinically significant corneal abnormalities or dystrophies
  • Previous intraocular or corneal/refractive surgery that may affect outcomes or increase risk
  • Conditions affecting intraocular lens stability
  • Diagnosed degenerative visual disorders or other eye pathologies predicting poor visual acuity
  • Current systemic or ocular medications with significant ocular side effects
  • Clinically significant gonioscopic abnormalities
  • Amblyopia, strabismus, or single eye status
  • Rubella, congenital, traumatic, or complicated cataracts
  • History or current anterior or posterior segment inflammation
  • Microphthalmos or macrophthalmos
  • Pupil abnormalities
  • Pseudoexfoliation
  • Keratoconus or irregular astigmatism
  • Inability to measure keratometry or biometry
  • Pathologic miosis
  • Pregnancy, planned pregnancy, or lactation during the study
  • Inability to comply with protocol or likely non-cooperation
  • Legal or administrative restrictions on freedom
  • Participation in another clinical trial within the last 30 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Eye Hospital Zora

Sofia, Bulgaria

Actively Recruiting

2

Specialized Ophthalmological Hospital for Active Treatment

Sofia, Bulgaria

Actively Recruiting

3

Medical Center "Vereya"

Stara Zagora, Bulgaria

Actively Recruiting

4

Nemocnice Havlíčkův

Havlíčkův Brod, Czechia

Actively Recruiting

5

OFTEX ocni

Pardubice, Czechia

Actively Recruiting

6

Oční Centrum

Prague, Czechia

Actively Recruiting

7

Oculus Eye Clinic

Bucharest, Romania

Active, Not Recruiting

8

Ofta Total Clinic

Sibiu, Romania

Active, Not Recruiting

9

Medoptic Clinic

Suceava, Romania

Active, Not Recruiting

10

Oftalvist

Alicante, Spain

Actively Recruiting

11

Hospital Universitario Ramón y Cajal

Madrid, Spain

Actively Recruiting

12

OMIQ Hospital Universitari

Sant Cugat del Vallès, Spain

Active, Not Recruiting

13

University Hopital Complex of Santiago de Compostela

Santiago de Compostela, Spain

Active, Not Recruiting

14

Oftalvist

Valencia, Spain

Actively Recruiting

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Research Team

C

Carl Zeiss Meditec AG

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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