Comparing an Intraoperative vs. a Standard Wavefront Device

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03749798

Enrollment

Registered

2018-11-21

Start date

2018-09-01

Completion date

2019-12-01

Last updated

2018-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Cataract, Wavefront measurement

Brief summary

Comparison of intraoperative measured wavefront data with pre- and post-operative wavefront data.

Detailed description

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.

Interventions

PROCEDURECataract surgery

Intraoperative wavefront measurements will be carried out during cataract surgery

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 105 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Countries

Austria

Contacts

Primary ContactJulius Hienert, MD

office@viros.at01 910 21-57564

Backup ContactNino Hirnschall, MD