An interventional study of Subjective refraction and Autorefraction in Pseudophakia, sponsored by Vienna Institute for Research in Ocular Surgery. Completed at 1 site in Austria. Open to participants aged 21 Years to 105 Years. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by Vienna Institute for Research in Ocular Surgery · Not applicable, Interventional, and Diagnostic
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.
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.
54 studies on the registry are indexed under Pseudophakia; 8 are open to participants now.
This study's enrollment of 100 is above the median of 45 across 25 interventional studies indexed under Pseudophakia.
Browse Pseudophakia studies →Vienna Institute for Research in Ocular Surgery is the lead sponsor of 65 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjective and objective refraction will be performed in all patients
Device: Subjective refraction · Device: Autorefraction · Device: Wavefront aberrometry
Subjective refraction measurements will be performed by two testers for all the patients included
Five autorefraction measurements will be performed for all the patients included
Five wavefront measurements will be performed for all the patients included
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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Vienna Institute for Research in Ocular Surgery