Comparing an Intraoperative vs. a Standard Wavefront Device

NCT ID: NCT03749798

Last Updated: 2018-11-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-12-01

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.

Conditions

Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intraoperative wavefront measurement

Patients will be measured with an intraoperative wavefront device during cataract surgery

Group Type: EXPERIMENTAL

Cataract surgery

Intervention Type: PROCEDURE

Intraoperative wavefront measurements will be carried out during cataract surgery

Interventions

Cataract surgery

Intraoperative wavefront measurements will be carried out during cataract surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Prim. Prof. Dr. Oliver Findl, MBA

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Julius Hienert, MD

Role: CONTACT

office@viros.at

01 910 21-57564

Nino Hirnschall, MD

Role: CONTACT

office@viros.at

01 910 21-57564

Facility Contacts

Julius Hienert, MD

Role: primary

office@viros.at

01 910 21-57564

Nino Hirnschall, MD

Role: backup

office@viros.at

01 910 21-57564

Other Identifiers

HeLeNa

Identifier Type: -

Identifier Source: org_study_id