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Safety and Efficacy of the Transform™ Corneal Allograft for Hyperopia Correction

Primary Purpose

Hyperopia

Status

Withdrawn

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Intrastromal TCA Inlay

About this trial

This is an interventional treatment trial for Hyperopia focused on measuring Intrastromal, Corneal, Allograft

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Gemini Augenlaser Wien
Sekhraft Augenzentrum Wien
Medipolis Wilrijk
Hospital Pierre Paul Riquet
Institute Laser Vision Noemie de Rothschild, Fondation Ophthalmolique Adolphe de Rothschild
Wellington Eye Clinic
Laser Vista
Eye Clinic Orasis AG
Optegra Eye Hospital
Corneo Plastic Unit and Eye Bank Queen Victoria Hospital
Centre for Sight

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intrastromal TCA Inlay

Arm Description

Implant Intrastromal TCA using femto-second laser surgery It is expected to be carried out once only during the study duration

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03671096

First Posted

September 6, 2018

Last Updated

March 9, 2020

Sponsor

Allotex, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03671096

Brief Title

Safety and Efficacy of the Transform™ Corneal Allograft for Hyperopia Correction

Official Title

A Prospective Multi Center Clinical Study to Evaluate the Safety And Effectiveness of the Transform™ Corneal Allograft (TCA) for Treatment of Hyperopia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Withdrawn

Why Stopped

The sponsor determined at one study (PRO-010) was sufficient

Study Start Date

October 2018 (Anticipated)

Primary Completion Date

January 2021 (Anticipated)

Study Completion Date

January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allotex, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperopia

Keywords

Intrastromal, Corneal, Allograft

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intrastromal TCA Inlay

Arm Type

Experimental

Arm Description

Implant Intrastromal TCA using femto-second laser surgery It is expected to be carried out once only during the study duration

Intervention Type

Other

Intervention Name(s)

Intrastromal TCA Inlay

Intervention Description

An intrastromal inlay that will be provided to correct the required hyperopic correction

Primary Outcome Measure Information:

Title

Assessment of the accuracy and stability of hyperopia refractive correction following intervention with the Transform™ Corneal Allograft inlay.

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen Slade, MD

Organizational Affiliation

Study Medical Monitor/Consultant

Official's Role

Study Director

Facility Information:

Facility Name

Gemini Augenlaser Wien

City

Vienna

State/Province

Opernring 1

ZIP/Postal Code

1010

Country

Austria

Facility Name

Sekhraft Augenzentrum Wien

City

Vienna

ZIP/Postal Code

1010

Country

Austria

Facility Name

Medipolis Wilrijk

City

Antwerp

State/Province

Boomsesteenweg 223

ZIP/Postal Code

B-2610

Country

Belgium

Facility Name

Hospital Pierre Paul Riquet

City

Toulouse

State/Province

Purpan

ZIP/Postal Code

31300

Country

France

Facility Name

Institute Laser Vision Noemie de Rothschild, Fondation Ophthalmolique Adolphe de Rothschild

City

Paris

ZIP/Postal Code

75019

Country

France

Facility Name

Wellington Eye Clinic

City

Dublin

State/Province

Beacon Court Sandyford

ZIP/Postal Code

Country

Ireland

Facility Name

Laser Vista

City

Basel

ZIP/Postal Code

4051

Country

Switzerland

Facility Name

Eye Clinic Orasis AG

City

Reinach AG

ZIP/Postal Code

5734

Country

Switzerland

Facility Name

Optegra Eye Hospital

City

London

State/Province

Marylebone

ZIP/Postal Code

W1G 9HT

Country

United Kingdom

Facility Name

Corneo Plastic Unit and Eye Bank Queen Victoria Hospital

City

East Grinstead

ZIP/Postal Code

RH19 3DZ

Country

United Kingdom

Facility Name

Centre for Sight

City

London

ZIP/Postal Code

W1G 8HZ

Country

United Kingdom

12. IPD Sharing Statement

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Safety and Efficacy of the Transform™ Corneal Allograft for Hyperopia Correction

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