Observational Study - TA- 2025-1 (TA OS 2025-1)

June 3, 2025 updated by: Haag-Streit AG

Toric Alignment Observational Study 2025-1

This multi-centric, prospective observational study collects biometric datasets as well as associated video recordings of the surgical procedure.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • East Valley Ophthalmology
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pacific Clear Vision Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any individual over the age of 21 seeking elective cataract surgery at the study sites.

Description

Inclusion Criteria:

  • diagnosed with cataracts (any grade),
  • Seeking cataract treatment,
  • willing to provide informed consent.

Exclusion Criteria:

  • Active ocular infections or trauma.
  • Poor fixation ability (e.g., severe nystagmus).
  • Prior intraocular surgery.
  • Seeking toric IOL implantation requiring ink marking.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biometric data
Time Frame: one-time measurement before surgery
collect anonymised biometric data from patients undergoing elective cataract surgery
one-time measurement before surgery
Video recording
Time Frame: during the surgical procedure
collect anonymised video recording of surgical procedure from patients undergoing elective cataract surgery
during the surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Software algorith
Time Frame: up to 6 months
Verification of software algorithms that use the biometric data to analyse the video recordings.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haag-Streit AG

Investigators

  • Study Chair: Jan Rübel, PhD, Haag-Streit
  • Study Director: Julian V Kool van Langenberghe, ing, Haag-Streit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

June 3, 2025

First Posted (Actual)

June 6, 2025

Study Record Updates

Last Update Posted (Actual)

June 6, 2025

Last Update Submitted That Met QC Criteria

June 3, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9360002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Astigmatism

Clinical Trials on Optical Biometry

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe