Safety and Efficacy of an Intrastromal Transform Corneal Allograft (TCA) for Presbyopia Correction - Long Term Follow-up
NCT ID: NCT06310252
Last Updated: 2024-12-19
Study Results
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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COMPLETED
71 participants
OBSERVATIONAL
2024-02-13
2024-11-22
Brief Summary
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A maximum of 101 eyes of qualified and consented subjects will undergo long term follow-up after instrastromal implantation of the TCA for presbyopia.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Opthalmic assessments
The participants will undergo the following assessments:
1. Pupil size measurement
2. Manifest refraction (no autorefraction)
3. Monocular in both eyes and binocular uncorrected visual acuity (photopic):
* Distance (4 m)
* Intermediate (80 cm)
* Near (40 cm)
4. Monocular best corrected visual acuity (photopic):
* Distance (4 m)
* Near (40 cm)
* Distance-corrected near (40 cm)
5. Monocular and binocular mesopic (with and without glare) and photopic (without glare) contrast sensitivity testing (subgroup)
6. Slit lamp examination
7. Tear breakup time
8. Placido Corneal topography, keratometry and pachymetry
9. Optical coherence tomography including epithelium mapping (subgroup)
10. Applanation intraocular pressure
11. Cycloplegic refraction
12. Dilated fundus examination
13. Wavefront aberrometry (subgroup)
14. Adverse events
Eligibility Criteria
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Inclusion Criteria
* Subjects must be willing and able to return for one scheduled follow-up examinations.
* Subjects must have undergone implantation with the TCA under study protocol PRO-010 between April 24, 2019 and October 31, 2019.
ALL
Yes
Sponsors
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Allotex, Inc.
INDUSTRY
Responsible Party
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Locations
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Gemini - Oční klinika Zlín
Zlín, , Czechia
Wellington Eye Clinic
Dublin, , Ireland
Medipol University
Istanbul, , Turkey (Türkiye)
Centre For Sight
East Grinstead, , United Kingdom
Eye Clinic London
London, , United Kingdom
Centre For Sight
London, , United Kingdom
Centre For Sight
Oxshott, , United Kingdom
Countries
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Other Identifiers
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PRO_010-2023
Identifier Type: -
Identifier Source: org_study_id