Subjective and Objective Refraction in Pseudophakic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-20

Study Completion Date

2014-08-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pseudophakia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Refraction reproducibility and agreement

Subjective and objective refraction will be performed in all patients

Group Type OTHER

Subjective refraction

Intervention Type DEVICE

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

Autorefraction

Intervention Type DEVICE

Five autorefraction measurements will be performed for all the patients included

Wavefront aberrometry

Intervention Type DEVICE

Five wavefront measurements will be performed for all the patients included

Interventions

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Subjective refraction

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

Intervention Type DEVICE

Autorefraction

Five autorefraction measurements will be performed for all the patients included

Intervention Type DEVICE

Wavefront aberrometry

Five wavefront measurements will be performed for all the patients included

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No