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

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

Study Overview

• Status: Unknown
• Conditions: Cataract
• Intervention / Treatment: Procedure: Cataract surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julius Hienert, MD; Phone Number: 01 910 21-57564; Email: office@viros.at
• Study Contact Backup: Name: Nino Hirnschall, MD; Phone Number: 01 910 21-57564; Email: office@viros.at

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Recruiting
    • Vienna Institute for Research in Ocular Surgery (VIROS)
    • Contact: Julius Hienert, MD; Phone Number: 01 910 21-57564; Email: office@viros.at
    • Contact: Nino Hirnschall, MD; Phone Number: 01 910 21-57564; Email: office@viros.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraoperative wavefront measurement; Patients will be measured with an intraoperative wavefront device during cataract surgery	Procedure: Cataract surgery; Intraoperative wavefront measurements will be carried out during cataract surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Prim. Prof. Dr. Oliver Findl, MBA

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 20, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Cataract; Wavefront measurement
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: HeLeNa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No