Subjective and Objective Refraction in Pseudophakic Patients

• Sponsor: Vienna Institute for Research in Ocular Surgery (Other)
• Overall Status: Completed
• CT.gov ID: NCT04319497
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Actual Duration (Months): 17
• Patients Per Site Per Month: 5.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pseudophakia	Device: Subjective refraction; Device: Autorefraction; Device: Wavefront aberrometry	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Agreement and Variability of Subjective Refraction, Autorefraction, and Wavefront Aberrometry in Pseudophakic Patients
• Actual Study Start Date: Mar 20, 2013
• Actual Primary Completion Date: Aug 20, 2014
• Actual Study Completion Date: Aug 20, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Evaluation of the agreement between the subjective refraction measurements (in dioptres) of two examiners [12 months]

   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

1. Evaluation of reproducibility between the subjective refraction measurements between two study visits [12 months]

   To compare reproducibility of subjective refraction measurements between study visit 1 and study visit 2 Wilcoxon-signed rank test will be applied.

2. Evaluation of the agreement between the measurements performed by subjective refraction, autorefraction, and wavefront aberrometry (in dioptres) [12 months]

   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.

3. Evaluation of the reproducibility between measurements done with subjective refraction, autorefraction, and wavefront aberrometry in dioptres [12 months]

   To compare reproducibility between the 3 measurement methods in dioptres, Friedman's multiple comparison will be applied.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 105 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vienna Institute for Research in Ocular Surgery (VIROS)	Vienna		Austria	1140

Sponsors and Collaborators

• Vienna Institute for Research in Ocular Surgery

Investigators

• Principal Investigator: Oliver Findl, Prof., VIROS, Hanusch Hospital Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
• ClinicalTrials.gov Identifier: NCT04319497
• Other Study ID Numbers: Refraction
• First Posted: Mar 24, 2020
• Last Update Posted: Mar 24, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery: Subjective Refraction; Autorefraction; Wavefront Aberrometry
• Additional relevant MeSH terms: Pseudophakia

Study Results

No Results Posted as of Mar 24, 2020