NCT04319497

Brief Summary

Targeting of post-cataract refraction depends mainly on the prediction of the post-operative lens position, but also on the post-operative refraction itself. Hence, aim of this study is to evaluate the agreement and variability of subjective refraction performed by two independent examiners, autorefraction, and wavefront aberrometry in pseudophakic patients after uneventful cataract surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

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

March 20, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2014

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

March 19, 2020

Last Update Submit

March 20, 2020

Conditions

Pseudophakia

Keywords

Subjective RefractionAutorefractionWavefront Aberrometry

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the agreement between the subjective refraction measurements (in dioptres) of two examiners

    To show the number of measurements within the limits of agreement, Bland-Altman plots will be created for subjective refraction measurements in dioptres between examiner 1 and examiner 2.

    12 months

Secondary Outcomes (3)

  • Evaluation of reproducibility between the subjective refraction measurements between two study visits

    12 months

  • Evaluation of the agreement between the measurements performed by subjective refraction, autorefraction, and wavefront aberrometry (in dioptres)

    12 months

  • Evaluation of the reproducibility between measurements done with subjective refraction, autorefraction, and wavefront aberrometry in dioptres

    12 months

Study Arms (1)

Refraction reproducibility and agreement

OTHER

Subjective and objective refraction will be performed in all patients

Device: Subjective refractionDevice: AutorefractionDevice: Wavefront aberrometry

Interventions

Subjective refractionDEVICE

Subjective refraction measurements will be performed by two testers for all the patients included

Refraction reproducibility and agreement
AutorefractionDEVICE

Five autorefraction measurements will be performed for all the patients included

Refraction reproducibility and agreement
Wavefront aberrometryDEVICE

Five wavefront measurements will be performed for all the patients included

Refraction reproducibility and agreement

Eligibility Criteria

Age21 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Minimum age: 21 years
  • Cataract surgery (at least 8 weeks post-surgery)
  • written informed consent

You may not qualify if:

  • Complications during or after cataract surgery
  • Ophthalmic diseases, that might interfere with measurements (macular degeneration, glaucoma, diabetic retinopathia)
  • Ophthalmic surgery other than cataract surgery
  • Clinically significant posterior capsule opacification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, 1140, Austria

Location

Related Publications (1)

  • Ruiss M, Findl O, Draschl P, Harrer-Seely A, Hirnschall N. Agreement and variability of subjective refraction, autorefraction, and wavefront aberrometry in pseudophakic patients. J Cataract Refract Surg. 2021 Aug 1;47(8):1056-1063. doi: 10.1097/j.jcrs.0000000000000583.

    PMID: 34292891DERIVED

MeSH Terms

Conditions

Pseudophakia

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Oliver Findl, Prof.

    VIROS, Hanusch Hospital Vienna

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 24, 2020

Study Start

March 20, 2013

Primary Completion

August 20, 2014

Study Completion

August 20, 2014

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)