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OpenTrials
Enrolling by Invitation

NCT Number: NCT07007897

Observational Study - TA- 2025-1

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

Enrolling by Invitation

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Key information

Conditions

Astigmatism Eye Diseases Refractive Errors

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

East Valley Ophthalmology, Mesa, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optical Biometry

Device

Biometric measurements of the eye used for surgical planning will be obtained.

cataract surgery

Procedure

A video recording of the surgical procedure will be obtained.

Primary outcomes

  1. Biometric data

    Time frame: one-time measurement before surgery

    collect anonymised biometric data from patients undergoing elective cataract surgery

  2. Video recording

    Time frame: during the surgical procedure

    collect anonymised video recording of surgical procedure from patients undergoing elective cataract surgery

Secondary outcomes

  1. Software algorith

    Time frame: up to 6 months

    Verification of software algorithms that use the biometric data to analyse the video recordings.

Sponsors and collaborators

Lead sponsor

Haag-Streit AG

Industry

Registry information

Official study title

Toric Alignment Observational Study 2025-1

Acronym: TA OS 2025-1

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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