Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03671096
Other study ID # PRO_012
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2018
Est. completion date January 2021

Study information

Verified date March 2020
Source Allotex, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2021
Est. primary completion date January 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria:

- Subjects must have signed the written informed consent form and been given a copy.

- 21 years of age or older on the day the surgery is performed.

- Best distance corrected visual acuity of 20/20 or better in both eyes.

- Near visual acuity correctable to at least 20/20 in both eyes.

- Manifest refraction spherical equivalent (MRSE) between +1.00 and +6.00 D with no more than 0.75 D of refractive cylinder in both eyes.

- Stable vision, i.e. MSRE within 0.50 D over prior 12 months in both eyes.

- Contact lens wearers must discontinue hard or rigid gas permeable lenses for at least 2 weeks and discontinue soft lenses for at least 3 days prior to baseline examination in both eyes.

- Contact lens wearers must have two (2) central keratometry readings with regular mires and two (2) manifest refractions taken at least one week apart, with no contact lens wear between. Keratometric values must not differ by more than ±0.50 D in any meridian and MRSE values must not differ more than ±0.50 D in both eyes.

- Average corneal power of = 41.00 D and = 47.00 D in both eyes.

- Anticipated postoperative average corneal power (preoperative average corneal power + intended correction) = 50.00 D in both eyes.

- Subjects must be willing and able to return for scheduled follow-up examinations for 24 months after surgery of the fellow eye.

Exclusion Criteria:

- Difference of > 0.75 D between the manifest refraction spherical equivalent and the cycloplegic refraction spherical equivalent in either eye.

- Anterior segment pathology in either eye.

- Signs or symptoms of clinically significant cataracts in either eye.

- Residual, recurrent, active ocular or uncontrolled eyelid disease, or any corneal abnormality (including endothelial dystrophy, recurrent corneal erosion, etc.) in either eye.

- Central corneal thickness <470 microns in either eye.

- Residual stromal thickness of <300 microns in either eye.

- Topographic signs of keratoconus (or keratoconus suspect) or other ectatic disorders in either eye.

- Subjects with clinically significant dry eyes, as determined by Tear Breakup Time (TBUT) of < 7 seconds or the presence of greater than mild symptoms of dryness or discomfort or SPK greater than grade 1.

- Distorted or unclear corneal mires on topography maps of either eye.

- Macular degeneration, retinal detachment, or any other fundus pathology that would prevent an acceptable visual outcome in either eye.

- Any prior ocular surgery in either eye.

- History of herpes zoster or herpes simplex keratitis in either eye.

- History of steroid-responsive rise in intraocular pressure (IOP), preoperative IOP >21 mm Hg, glaucoma, or are a glaucoma suspect in either eye.

- Using systemic medications with significant ocular side effects.

- Pregnant, lactating, or planning to become pregnant during the course of the study.

- Known sensitivity to planned study concomitant medications.

- Participating in any ophthalmic drug or device clinical trial during the time of this clinical investigation.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Intrastromal TCA Inlay
An intrastromal inlay that will be provided to correct the required hyperopic correction

Locations

Country Name City State
Austria Gemini Augenlaser Wien Vienna Opernring 1
Austria Sekhraft Augenzentrum Wien Vienna
Belgium Medipolis Wilrijk Antwerp Boomsesteenweg 223
France Institute Laser Vision Noemie de Rothschild, Fondation Ophthalmolique Adolphe de Rothschild Paris
France Hospital Pierre Paul Riquet Toulouse Purpan
Ireland Wellington Eye Clinic Dublin Beacon Court Sandyford
Switzerland Laser Vista Basel
Switzerland Eye Clinic Orasis AG Reinach AG
United Kingdom Corneo Plastic Unit and Eye Bank Queen Victoria Hospital East Grinstead
United Kingdom Centre for Sight London
United Kingdom Optegra Eye Hospital London Marylebone

Sponsors (1)

Lead Sponsor Collaborator
Allotex, Inc.

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Ireland,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of the accuracy and stability of hyperopia refractive correction following intervention with the Transform™ Corneal Allograft inlay. 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. 6 months
See also
  Status Clinical Trial Phase
Completed NCT06046209 - Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens N/A
Completed NCT05656885 - Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses N/A
Completed NCT02423109 - Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses N/A
Completed NCT01392950 - Clinical Study of Clariti Monthly Contact Lens N/A
Withdrawn NCT00765960 - Evaluation of Outcomes Using the Amo Advanced CustomVue Ilasik Procedure
Completed NCT00520689 - Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens Phase 3
Completed NCT05538182 - Zimbabwe Eyecare And Learning(ZEAL):Formative Research on Hyperopia and Educational Outcomes in Primary School Children N/A
Enrolling by invitation NCT05976750 - Air Optix® Night and Day® Aqua Daily Wear
Completed NCT02575911 - Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study N/A
Completed NCT05735990 - Retrospective Clinical Investigation of the Safety and Performance of 640PM Trifocal IOL Implantation in Patients With Cataract and/or Ametropia (Hyperopia, Myopia) and/or Presbyopia
Recruiting NCT02279446 - Development of a Validated Chart for Intermediate Vision Assessment N/A
Completed NCT02060539 - Multicenter Dispensing Study of Biofinity Lenses in Extended Range N/A
Completed NCT01951573 - Evaluation of a New Daily Disposable Multifocal Contact Lens Design N/A
Completed NCT01467557 - Daily Disposable Performance of 1•DAY ACUVUE® TruEye™ and 1•DAY ACUVUE® MOIST® With LACREON® TECHNOLOGY
Completed NCT01228591 - Pilot Dispensing Evaluation of a Plus Power Lens N/A
Completed NCT03722784 - Evaluation of Silicone Hydrogel Daily Wear Contact Lenses for Up to One (1) Month of Daily Wear N/A
Completed NCT03688672 - Apioc Contact Lens Feasibility N/A
Completed NCT05741450 - A Clinical Comparison of Two Soft Contact Lenses N/A
Completed NCT01912781 - Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Gas Permeable Contact Lens Wearers N/A
Completed NCT01684046 - Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2 N/A