Subjective and Objective Refraction in Pseudophakic Patients

Agreement and Variability of Subjective Refraction, Autorefraction, and Wavefront Aberrometry in Pseudophakic Patients

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.

Study Overview

• Status: Completed
• Conditions: Pseudophakia
• Intervention / Treatment: Device: Subjective refraction; Device: Autorefraction; Device: Wavefront aberrometry

Detailed Description

One of the main goals of modern cataract surgery, beside removing the cataractous lens, is to achieve the patient's desired post-operative refraction. Targeting this post-operative refraction depends mainly on the prediction of the post-operative lens position and the post-operative refraction itself. Reason for the contributing effect of post-operative refraction in the error-propagation analyses is that refraction in phakic patients was shown to have only moderate reproducibility.

In the past, different studies evaluated refraction methods. However, there is no study that included reproducibility of subjective refraction in pseudophakic patients and compares it with objective refraction methods (autorefraction, wavefront aberrometry).

100 eyes of 100 patients, which underwent uneventful cataract surgery, will be included in the study. Refraction of one eye of each patient will be tested using subjective refraction by two different examiners, autorefraction, and wavefront aberrometry at two separate occasions.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Vienna Institute for Research in Ocular Surgery (VIROS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 105 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Refraction reproducibility and agreement; Subjective and objective refraction will be performed in all patients	Device: Subjective refraction; Subjective refraction measurements will be performed by two testers for all the patients included; Device: Autorefraction; Five autorefraction measurements will be performed for all the patients included; Device: Wavefront aberrometry; Five wavefront measurements will be performed for all the patients included

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of reproducibility between the subjective refraction measurements between two study visits	To compare reproducibility of subjective refraction measurements between study visit 1 and study visit 2 Wilcoxon-signed rank test will be applied.	12 months
Evaluation of the agreement between the measurements performed by subjective refraction, autorefraction, and wavefront aberrometry (in dioptres)	To show the number of measurements within the limits of agreement, Bland-Altman plots will be created for subjective refraction measurements in dioptres between the 3 measurement methods.	12 months
Evaluation of the reproducibility between measurements done with subjective refraction, autorefraction, and wavefront aberrometry in dioptres	To compare reproducibility between the 3 measurement methods in dioptres, Friedman's multiple comparison will be applied.	12 months

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2013
• Primary Completion (ACTUAL): August 20, 2014
• Study Completion (ACTUAL): August 20, 2014

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (ACTUAL): March 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 20, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Subjective Refraction; Autorefraction; Wavefront Aberrometry
• Additional Relevant MeSH Terms: Pseudophakia
• Other Study ID Numbers: Refraction

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No