Clinical trial NCT04319497: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pseudophakia
Keywords: Subjective Refraction
Autorefraction
Wavefront Aberrometry
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Evaluation of the agreement between the subjective refraction measurements (in dioptres) of two examiners
timeFrame: 12 months
Secondary outcomes:
measure: Evaluation of reproducibility between the subjective refraction measurements between two study visits
timeFrame: 12 months
measure: Evaluation of the agreement between the measurements performed by subjective refraction, autorefraction, and wavefront aberrometry (in dioptres)
timeFrame: 12 months
measure: Evaluation of the reproducibility between measurements done with subjective refraction, autorefraction, and wavefront aberrometry in dioptres
timeFrame: 12 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS)
Study officials:
affiliation: VIROS, Hanusch Hospital Vienna
name: Oliver Findl, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.