VCSEL Based Optical Swept Source Biometry

NCT06551480 | Completed

• 1 other identifier: MUW_VBOB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Optical interferometric biometry is a non-invasive and highly precise method for measuring eye length and intraocular distances. The method already exists as commercial devices (e.g. IOLMaster, Carl Zeiss Meditec AG). A major cost factor of the devices available on the market is the laser used. The use of a much cheaper laser could significantly reduce the price of these devices, which would lead to greater availability of this technology in developing countries. This would make it possible to replace the ultrasound methods used to date and thus enable contact-free measurements, which in turn can reduce the spread of infectious diseases.The study investigates the use of a thermally tunable vertical cavity surface emitting laser (VCSEL) for optical swept source biometry.

Conditions

Cataract; Myopia

Outcome Measures

Primary Outcomes (2)

• axial length

  limits of agreement between the optical biometers (mm)

  1 day

• anterior chamber depth

  limits of agreement between the optical biometers (mm)

  1 day

Secondary Outcomes (1)

• intraocular distances

  1 day

Study Arms (1)

Pilot Study

EXPERIMENTAL

Pilot study in healthy participants and cataract patients

Device: Biometry

Interventions

Biometry DEVICE

Only one eye from each patient will be included in the study. All subjects and patients included in the study will undergo biometric measurements with both devices (IOL master 500 and VCSEL based swept source optical biometry).

Pilot Study

Eligibility Criteria

• Age: 19 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy participants
• cataract patients (LOCS III grading)
• written informed consent

You may not qualify if:

• corneal pathology that would significantly influence biometric measurements
• pathologies that could affect fixation abilities other than cataract
• pregnancy (for women in reproductive age a pregnancy test will be performed)

Sponsors & Collaborators

• Rainer Leitgeb: lead
• Mein Hanusch-Krankenhaus: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Cataract; Myopia

Interventions

Biometry

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Intervention Hierarchy (Ancestors)

Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Rainer Leitgeb, PhD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Rainer Leitgeb

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: August 27, 2021
• Primary Completion: February 1, 2024
• Study Completion: May 1, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)