NCT03751241

Brief Summary

Influence of different ophthalmic conditions after cataract surgery (extended range of vision IOL (EROV) with micromonovision, minimonovision with standard IOL and single focus distance vision with standard IOL) on reading quality.

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
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

4 years

First QC Date

November 21, 2018

Last Update Submit

February 26, 2019

Conditions

Keywords

PseudophakiaReading speed

Outcome Measures

Primary Outcomes (1)

  • Reading speed

    Reading speed in the 3 different IOL groups (EROV, monofocal, minimonovision) will be assessed using the EyeTracker device. Patients are asked to read 4 texts with different contrast levels. The faster the patients can read the texts, the better the outcome.

    12 months

Study Arms (1)

Intraocular lens types

EXPERIMENTAL

Patients with different types of IOLs (EROV, monofocal, minimonovision) are tested for their reading quality using the EyeTracker device

Device: EyeTracker

Interventions

The EyeTracker is used to determine reading quality of patients with different intraocular lens types (EROV, monofocal, minimonovision)

Intraocular lens types

Eligibility Criteria

Age21 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21 and older
  • Written informed consent
  • Extended range of vision group: Patients with EROV intraocular lenses and a best-corrected Snellen VA above 0.7 in the weaker eye. Furthermore, the VA of the better eye has to be at least 0.8 (uncorrected visual acuity) and the difference between the eyes should be between 0.5D and 1D)
  • Minimonovision standard IOL group: Patients with monofocal intraocular lenses and a best-corrected Snellen VA above 0.7 in the weaker eye. Furthermore, the VA of the better eye has to be at least 0.8 (uncorrected visual acuity) and the difference between the eyes should be between 0.75D and 1.50D)
  • Single focus distance vision group: Patients with monofocal intraocular lenses and a best-corrected Snellen VA above 0.7 in the weaker eye. Furthermore, the VA of the better eye has to be at least 0.8 (uncorrected visual acuity) and both eyes should have a spherical equivalent between +0.25D and -0.5D
  • Maximum of allowed Cylinder: +0.75D
  • Fluent in German

You may not qualify if:

  • Opacities, such as corneal scars
  • In case of pregnancy (pregnancy test will be taken preoperatively 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

Pseudophakia

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Sahand Amir-Asgari, MD

CONTACT

Stefan Palkovits, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 23, 2018

Study Start

January 1, 2017

Primary Completion

January 1, 2021

Study Completion

January 1, 2022

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations