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Subjective and Objective Refraction in Pseudophakic Patients

V

Vienna Institute for Research in Ocular Surgery

Status

Completed

Conditions

Pseudophakia

Treatments

Device: Wavefront aberrometry
Device: Subjective refraction
Device: Autorefraction

Study type

Interventional

Funder types

Other

Identifiers

NCT04319497
Refraction

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

21 to 105 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Refraction reproducibility and agreement
Other group
Description:
Subjective and objective refraction will be performed in all patients
Treatment:
Device: Wavefront aberrometry
Device: Subjective refraction
Device: Autorefraction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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