Comparing an Intraoperative vs. a Standard Wavefront Device

Study Overview
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Brief Summary
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Comparison of intraoperative measured wavefront data with pre- and post-operative wavefront data.

Detailed Description
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Different technologies are in use for measuring wavefront aberrations, such as Hartmann-Shack wavefront aberrometry, Tscherning aberrometry, Laser Raytracing and automatic retinoscopy. While Hartmann-Shack wavefront aberrometry, the most widespread of these techniques, uses a lenslet array to record distortions of light bundles coming from a single source form the retina, Tscherning aberrometry uses a matrix of pinholes. Laser Ray Tracing in contrast measures the aberration of a laser beam at different locations. All three systems compare distorsions of the measured light beams with a perfect optical system to calculate the wavefront errors. Repeatability of wavefront devices was studied in young healthy subjects and different devices have been compared to each other. These results do not represent the typical cataract patient. Several factors, such as tear film instability and pupil size, have an influence on the measurements and these factors may change significantly with age. Intraoperative measured data could help to get a better information about wavefront aberrations.

Official Title
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To Collect and Compare Data With an Intraoperative Wavefront Device (HeLeNa) to a Standard Wavefront Device: an Explorative Pilot Study

Conditions
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Cataract

Intervention / Treatment
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* Procedure: Cataract surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cataract Age 21 and older Able to understand the patient information Willing to follow the instructions and attend all follow-up visits Willing to sign informed consent prior to surgery Exclusion Criteria: Relevant other ophthalmic diseases that are likely to reduce the refractive outcome, such as pseudoexfoliation syndrome, traumatic cataract, severe corneal scars Previous ocular surgeries on the study eye Patients who are not able to cooperate, with eccentric fixation or insufficient ability to fixate (tremor, nystagmus) Pregnant or lactating women (pregnancy testing will be performed preoperatively on women of reproductive age)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraoperative wavefront measurement<br>Patients will be measured with an intraoperative wavefront device during cataract surgery | Procedure: Cataract surgery<br>* Intraoperative wavefront measurements will be carried out during cataract surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wavefront aberration measurements | Measurements of wavefront aberrations using an Hartmann-Shack device will be compared at different time points (pre-, intra-, postoperative). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Wavefront measurement