NCT05704686

Brief Summary

Single-center, retrospective, open-label observational study aiming to evaluate visual outcomes and patient satisfaction after bilateral implantation of Isopure® EDOF-IOL with a mono-minovision target.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

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

April 26, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

January 19, 2023

Last Update Submit

January 19, 2023

Conditions

Lens OpacitiesCataractPseudophakia

Outcome Measures

Primary Outcomes (6)

  • UDVA(m)

    Monocular Uncorrected Distance Visual Acuity

    4-6 weeks postoperatively

  • CDVA(m)

    Monocular Corrected Distance Visual Acuity

    4-6 weeks postoperatively

  • UDVA(b)

    Binocular Uncorrected Distance Visual Acuity

    4-6 weeks postoperatively

  • UIVA

    Binocular Uncorrected Intermediate Visual Acuity (80 cm)

    4-6 weeks postoperatively

  • UNVA

    Binocular Uncorrected Near Visual Acuity (40 cm)

    4-6 weeks postoperatively

  • Defocus curve

    Binocular distance-corrected defocus curve analysis simulating visual acuities at different distances.

    4-6 weeks postoperatively

Secondary Outcomes (2)

  • Patient satisfaction with the visual outcome

    4-6 weeks postoperatively and 4-6 months postoperatively

  • Subjective rating of visual phenomena

    4-6 weeks postoperatively and 4-6 months postoperatively

Other Outcomes (4)

  • Impact of OCCI on residual refractive cylinder

    4-6 weeks postoperatively

  • Impact of OCCI on uncorrected binocular visual acuity

    4-6 weeks postoperatively

  • Impact of OCCI on uncorrected monocular visual acuity

    4-6 weeks postoperatively

  • +1 more other outcomes

Interventions

Isopure 1.2.3 intraocular EDOF lens implantationDEVICE

Bilateral Isopure 1.2.3 intraocular EDOF IOL implantation during a routine cataract surgery.

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients undergoing routine cataract surgery and having opted for the implantation of an EDOF intraocular lens, in a primary ophthalmic clinic in Switzerland.

You may qualify if:

  • Male or female patients aged 50 years or older undergoing a routine cataract surgery and benefiting from bilateral IOL implantation with Isopure 1.2.3 IOL;
  • Patient's willingness to participate in the study;
  • Capacity to understand and sign an informed consent form and comply with examination procedures;
  • Cataractous eyes with no vision-impacting comorbidity (estimated visual potential post-surgery 0.2 logMAR or better);
  • Regular total corneal astigmatism ≤1.5 D (measured by topography method)

You may not qualify if:

  • Cooperation difficulties (distance from home, general health conditions, cognitive impairment);
  • Subjects with diagnosed extra- or intraocular vision-affecting comorbidities (macular degeneration, glaucoma or other retinal or optic nerve disorders, previous ocular surgeries, amblyopia);
  • Patients who previously benefitted from refractive surgery (PRK/LASIK) were included if no refractive surgery-related complications were noted (i.e: ectasia, corneal haze, dry eye);
  • History or presence of macular edema;
  • Perioperative complications;
  • Congenital, uveitic, traumatic or surgically-complicated cataract
  • Regular total corneal astigmatism \>1.5 dioptres (measured by topography method)
  • Irregular cornea, including keratotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vista Alpina Eye Clinic

Visp, 3930, Switzerland

Location

MeSH Terms

Conditions

CataractPseudophakia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kristof Vandekerckhove, MD

    Vista Alpina Eye Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Director and Founder, Vista Alpina Eye Clinic

Study Record Dates

First Submitted

January 19, 2023

First Posted

January 30, 2023

Study Start

April 26, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 30, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)