NCT07007897

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

March 17, 2025

Last Update Submit

June 3, 2025

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (2)

  • Biometric data

    collect anonymised biometric data from patients undergoing elective cataract surgery

    one-time measurement before surgery

  • Video recording

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

    during the surgical procedure

Secondary Outcomes (1)

  • Software algorith

    up to 6 months

Interventions

Optical BiometryDEVICE

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

Cataract SurgeryPROCEDURE

A video recording of the surgical procedure will be obtained.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

East Valley Ophthalmology

Mesa, Arizona, 85206, United States

Location

Pacific Clear Vision Institute

Eugene, Oregon, 97401, United States

Location

MeSH Terms

Conditions

Astigmatism

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Jan Rübel, PhD

    Haag-Streit

    STUDY CHAIR

  • Julian V Kool van Langenberghe, ing

    Haag-Streit

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2025

First Posted

June 6, 2025

Study Start

April 1, 2025

Primary Completion

July 30, 2025

Study Completion

December 31, 2025

Last Updated

June 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)