Subjective and Objective Refraction in Pseudophakic Patients
Primary Purpose
Pseudophakia
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Subjective refraction
Autorefraction
Wavefront aberrometry
Sponsored by
About this trial
This is an interventional diagnostic trial for Pseudophakia focused on measuring Subjective Refraction, Autorefraction, Wavefront Aberrometry
Eligibility Criteria
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
Sites / Locations
- Vienna Institute for Research in Ocular Surgery (VIROS)
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Refraction reproducibility and agreement
Arm Description
Subjective and objective refraction will be performed in all patients
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04319497
First Posted
March 19, 2020
Last Updated
March 20, 2020
Sponsor
Vienna Institute for Research in Ocular Surgery
1. Study Identification
Unique Protocol Identification Number
NCT04319497
Brief Title
Subjective and Objective Refraction in Pseudophakic Patients
Official Title
Agreement and Variability of Subjective Refraction, Autorefraction, and Wavefront Aberrometry in Pseudophakic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 20, 2013 (Actual)
Primary Completion Date
August 20, 2014 (Actual)
Study Completion Date
August 20, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudophakia
Keywords
Subjective Refraction, Autorefraction, Wavefront Aberrometry
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Refraction reproducibility and agreement
Arm Type
Other
Arm Description
Subjective and objective refraction will be performed in all patients
Intervention Type
Device
Intervention Name(s)
Subjective refraction
Intervention Description
Subjective refraction measurements will be performed by two testers for all the patients included
Intervention Type
Device
Intervention Name(s)
Autorefraction
Intervention Description
Five autorefraction measurements will be performed for all the patients included
Intervention Type
Device
Intervention Name(s)
Wavefront aberrometry
Intervention Description
Five wavefront measurements will be performed for all the patients included
Primary Outcome Measure Information:
Title
Evaluation of the agreement between the subjective refraction measurements (in dioptres) of two examiners
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Evaluation of reproducibility between the subjective refraction measurements between two study visits
Description
To compare reproducibility of subjective refraction measurements between study visit 1 and study visit 2 Wilcoxon-signed rank test will be applied.
Time Frame
12 months
Title
Evaluation of the agreement between the measurements performed by subjective refraction, autorefraction, and wavefront aberrometry (in dioptres)
Description
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.
Time Frame
12 months
Title
Evaluation of the reproducibility between measurements done with subjective refraction, autorefraction, and wavefront aberrometry in dioptres
Description
To compare reproducibility between the 3 measurement methods in dioptres, Friedman's multiple comparison will be applied.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, Prof.
Organizational Affiliation
VIROS, Hanusch Hospital Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS)
City
Vienna
ZIP/Postal Code
1140
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34292891
Citation
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.
Results Reference
derived
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Subjective and Objective Refraction in Pseudophakic Patients
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