Observational Study - TA- 2025-1

• Conditions: Astigmatism

• Registration Number: NCT07007897
• Lead Sponsor: Haag-Streit AG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-17
• Study Start: 2025-04-01
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06
• Primary Completion: 2025-07-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biometric data	one-time measurement before surgery	collect anonymised biometric data from patients undergoing elective cataract surgery
Video recording	during the surgical procedure	collect anonymised video recording of surgical procedure from patients undergoing elective cataract surgery

Secondary Outcome Measures

Name	Time	Method
Software algorith	up to 6 months	Verification of software algorithms that use the biometric data to analyse the video recordings.

Trial Locations

Locations (2)

East Valley Ophthalmology; 🇺🇸 Mesa, Arizona, United States

Pacific Clear Vision Institute; 🇺🇸 Eugene, Oregon, United States