Observational Study - TA- 2025-1

NCT ID: NCT07007897

Last Updated: 2025-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Conditions

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Astigmatism

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Optical Biometry

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

Intervention Type DEVICE

Cataract Surgery

A video recording of the surgical procedure will be obtained.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haag-Streit AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Rübel, PhD

Role: STUDY_CHAIR

Haag-Streit

Julian V Kool van Langenberghe, ing

Role: STUDY_DIRECTOR

Haag-Streit

Locations

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East Valley Ophthalmology

Mesa, Arizona, United States

Site Status

Pacific Clear Vision Institute

Eugene, Oregon, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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9360002

Identifier Type: -

Identifier Source: org_study_id

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