NCT03921762

Brief Summary

Comparison of the new extended depth of focus (EDOF) intraocular lens (IOL) ARTIS ACTIVE, which is designed as a twinset of IOLs, with the standard EDOF IOL AT Lara .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

October 29, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

April 17, 2019

Last Update Submit

April 17, 2019

Conditions

Cataract

Keywords

Cataract surgeryEnhanced depth of focus (EDOF)Intraocular lens

Outcome Measures

Primary Outcomes (1)

  • Assessment of binocular near visual acuity

    Binocular near visual acuity in logMar will be measured at 40 cm distance using an ETDRS visual acuity chart

    12 months

Secondary Outcomes (4)

  • Assessment of binocular far and intermediate visual acuity

    12 months

  • Assessment of halos

    12 months

  • Assessment of binocular contrast sensitivity

    12 months

  • Assessment of reading speed

    12 months

Study Arms (2)

Artis Active IOL

EXPERIMENTAL

Artis Active IOLs (Artis Active Mid, Artis Active Plus) will be implanted in patients eyes during cataract surgery

Procedure: Cataract surgery with Artis Active IOLs

AT Lara IOL

EXPERIMENTAL

AT Lara IOLs will be implanted in patients eyes during cataract surgery

Procedure: Cataract surgery with AT Lara IOLs

Interventions

Cataract surgery with Artis Active IOLsPROCEDURE

Patients will be implanted with the Artis Active IOLs during cataract surgery

Artis Active IOL
Cataract surgery with AT Lara IOLsPROCEDURE

Patients will be implanted with the AT Lara IOLs during cataract surgery

AT Lara IOL

Eligibility Criteria

Age50 Years - 105 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 50 years old
  • Bilateral age-related cataract
  • Qualify for bilateral implantation within 1 month
  • No previous refractive or ocular surgery
  • Available IOL dioptre range: 18 to 27D
  • Expected postoperative astigmatism ≤ 0.75D

You may not qualify if:

  • Pupil \> 4 mm
  • Occupation requiring night-time driving or any occupation incompatible with multifocality
  • Acute or chronic disease or illness that would increase risk or confound study results \[e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma, epiretinal membrane, cornea guttata, etc….\] found to be relevant by the investigators
  • Amblyopia, strabismus
  • Extremely shallow anterior chamber
  • Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, uveitis, Marfan's syndrome)
  • Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/ scotopic conditions)
  • Instability to place the intraocular lens safely at the location planned
  • Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, 1140, Austria

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Hannah Zwickl, MD

CONTACT

+43 1 91021/57564office@viros.at

Manuel Ruiss, MSc.

CONTACT

+43 1 91021/57564office@viros.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 19, 2019

Study Start

October 29, 2018

Primary Completion

April 1, 2020

Study Completion

October 1, 2020

Last Updated

April 19, 2019

Record last verified: 2019-04

Locations

AU(1)