Safety and Efficacy of the Transform™ Corneal Allograft for Hyperopia Correction
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|ClinicalTrials.gov Identifier: NCT03671096|
Recruitment Status : Withdrawn (The sponsor determined at one study (PRO-010) was sufficient)
First Posted : September 14, 2018
Last Update Posted : March 11, 2020
The objective of this clinical study is to evaluate the safety and effectiveness of intrastromal implantation of the Allotex TCA for improving distance vision in hyperopic subjects.
The overall objective with respect to visual outcome is to provide improved vision without the requirement of additional visual aids.
|Condition or disease||Intervention/treatment||Phase|
|Hyperopia||Other: Intrastromal TCA Inlay||Not Applicable|
This research provides a method to primarily correct refractive error by implanting a natural tissue graft. The level of correction will range from +1.00 to +6.00D which represents a range of refractive error that is difficult to manage using the same refractive surgical techniques used to correct myopia.
The other objective is to assess graft tolerance and safety so it can be applied to subjects that require other forms of visual correction.
This technique also permits the potential for graft removal if required and the patient should revert back to their previous prescription as no tissue is removed when applying this technique.
Beginning in 1949 with the pioneering work of Jose Barraquer, there has been an interest in using natural corneal tissue to change the refractive properties of the eye. In recent years, non-allogenic, synthetic corneal implants have received marketing approval in the United Stated and Europe for refractive purposes. Although synthetic implants are made of biocompatible materials they are not equivalent to an allogenic implant in terms of biocompatibility. The Allotex TCA is a piece of acellular cornea, sterilized with electron beam radiation and shaped to a particular shape using a laser. The availability of precise laser shaping systems and sterile corneas are the key factors that make the use of allogenic implants possible.
The implant is placed on the posterior surface of Bowmans layer of the cornea, in a corneal flap formed by a femtosecond laser.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Multi Center Clinical Study to Evaluate the Safety And Effectiveness of the Transform™ Corneal Allograft (TCA) for Treatment of Hyperopia|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Experimental: Intrastromal TCA Inlay
Implant Intrastromal TCA using femto-second laser surgery It is expected to be carried out once only during the study duration
Other: Intrastromal TCA Inlay
An intrastromal inlay that will be provided to correct the required hyperopic correction
- Assessment of the accuracy and stability of hyperopia refractive correction following intervention with the Transform™ Corneal Allograft inlay. [ Time Frame: 6 months ]The primary effectiveness endpoint is predictability of the refractive error within ±1.00 D of the intended refractive outcome at 6 months post-operatively. A minimum of 65% of eyes should have an achieved manifest refraction within ±1.00 D of the intended refractive outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671096
|Gemini Augenlaser Wien|
|Vienna, Opernring 1, Austria, 1010|
|Sekhraft Augenzentrum Wien|
|Vienna, Austria, 1010|
|Antwerp, Boomsesteenweg 223, Belgium, B-2610|
|Hospital Pierre Paul Riquet|
|Toulouse, Purpan, France, 31300|
|Institute Laser Vision Noemie de Rothschild, Fondation Ophthalmolique Adolphe de Rothschild|
|Paris, France, 75019|
|Wellington Eye Clinic|
|Dublin, Beacon Court Sandyford, Ireland, 18|
|Basel, Switzerland, 4051|
|Eye Clinic Orasis AG|
|Reinach AG, Switzerland, 5734|
|Optegra Eye Hospital|
|London, Marylebone, United Kingdom, W1G 9HT|
|Corneo Plastic Unit and Eye Bank Queen Victoria Hospital|
|East Grinstead, United Kingdom, RH19 3DZ|
|Centre for Sight|
|London, United Kingdom, W1G 8HZ|
|Study Director:||Stephen Slade, MD||Study Medical Monitor/Consultant|