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Safety and Efficacy of an Intrastromal Transform™ Corneal Allograft (TCA) for Presbyopia Correction

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ClinicalTrials.gov Identifier: NCT03671135
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Allotex, Inc.

Brief Summary:
The objective of this clinical study is to evaluate the safety and effectiveness of intrastromal implantation of the Allotex TransForm corneal allograft (TCA) for improving near vision in presbyopic subjects.

Condition or disease Intervention/treatment Phase
Presbyopia Other: TCA Intrastromal Inlay Not Applicable

Detailed Description:

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 TCA is placed in an intrastromal flap (Just beneath Bowmans layer) created using a femtosecond laser. The goal is to enhance the visual performance of the patient with a material that is 100% biocompatible and precisely shaped for the individual's needs.

Subjects must be presbyopic adults, needing from +1.75 D to +3.50 D of reading add in the non-dominant eye and must have uncorrected near visual acuity worse than 20/40 in the non-dominant eye. Bilateral treatments will not be allowed during this study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 121 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single group assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Intrastromal Implant of the Transform Corneal Allograft (TCA) for Providing Near Vision in Presbyopic Subjects
Actual Study Start Date : August 9, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TCA Intrastromal Inlay
A monocular intrastromal corneal inlay will be implanted.
Other: TCA Intrastromal Inlay
Anterior surface of Bowmans Layer Corneal Optical Correction Inlay




Primary Outcome Measures :
  1. Assessment of the accuracy and stability of Presbyopic refractive correction following intervention with the Transform™ Corneal Allograft Inlay. [ Time Frame: 6 months ]
    The primary effectiveness endpoint is an improvement in uncorrected near visual acuity (at 40 cm) at 6 months post-operativelyto20/40 or better. The goal is that more than 65% of eyes should have an uncorrected near visual acuity (UCNVA) of 20/40 or better at 6 months postoperatively.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provide informed consent, have signed the written informed consent form, and been given a copy.
  • Presbyopic adults, needing from +1.75 D to +3.50 D of reading add in the nondominant eye to improve near visual acuity at 40 cm by at least one line or more.
  • Uncorrected near visual acuity worse than 20/40 in the non-dominant eye.
  • Distance visual acuity correctable to at least 20/20 in both eyes.
  • Near visual acuity correctable to at least 20/20 in both eyes.
  • Manifest refraction spherical equivalent (MRSE) between -0.75 and +1.00 D with ≤0.75 D of refractive cylinder in the non-dominant eye.
  • Stable vision, i.e. MSRE within 0.50 D over prior 12 months in the non-dominant eye.
  • 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.
  • 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 the non-dominant eye.
  • Average corneal power of ≥ 35.00 D and ≤ 47.00 D in the non-dominant eye.
  • Subjects must be willing and able to return for scheduled follow-up examinations for 24 months after surgery.

Exclusion Criteria:

  • A difference of > 0.75 D between the manifest refraction spherical equivalent and the cycloplegic refraction spherical equivalent in the non-dominant eye.
  • Anterior segment pathology in the non-dominant eye.
  • Signs or symptoms of clinically significant cataracts in the non-dominant eye.
  • Residual, recurrent, active ocular or uncontrolled eyelid disease, or any corneal abnormality (including endothelial dystrophy, recurrent corneal erosion, etc.) in the non-dominant 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 the non-dominant eye.
  • Macular degeneration, retinal detachment, or any other fundus pathology that would prevent an acceptable visual outcome in the non-dominant eye.
  • Central corneal thickness <470 microns in either eye.
  • Any prior intraocular surgery except corneal refractive surgery is allowed if performed more than 6 months prior to study participation.
  • History of herpes zoster or herpes simplex keratitis in the non-dominant eye.
  • History of steroid-responsive rise in intraocular pressure (IOP), preoperative IOP >21 mm Hg, glaucoma, or are a glaucoma suspect in the non-dominant 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.

Information from the National Library of Medicine

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): NCT03671135


Contacts
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Contact: Maureen O'Connell 978-207-1245 maureen@oconnellregulatory.com

Locations
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Austria
Gemini Augenlaser Wien Not yet recruiting
Vienna, Opernring 1, Austria, 1010
Contact: Jaroslav Polisensky, MD    +43 1 9453267    j.polis@email.cz   
Principal Investigator: Pavel Stodulka, MD         
Sub-Investigator: Jaroslav Polisensky, MD         
Sub-Investigator: Tatiana Makisova, MD         
Sekhraft Augenzentrum Wien Not yet recruiting
Vienna, Austria, 1010
Contact: Maus Matthias, MD    +43 1-9048889      
Contact: Kristina Liney       liney@sehkraft.at   
Principal Investigator: Maus Matthias         
Belgium
Medipolis Wilrijk Enrolling by invitation
Antwerp, Boomsesteenweg 223, Belgium, B-2610
France
Hospital Pierre Paul Riquet Not yet recruiting
Toulouse, Purpan, France, 31300
Contact: Claire Triozon    +33 5 61 77 77 52    clairetriozon5@hotmail.com   
Principal Investigator: Francois Malecaze, MD         
Institute Laser Vision Noemie de Rothschild, Fondation Ophthalmolique Adolphe de Rothschild Not yet recruiting
Paris, France, 75019
Contact: Vivien Vasseur    +33 1 48 03 64 40    vvasseur@for.paris   
Contact: Aimee Myers         
Principal Investigator: Damien Gatinel, MD         
Ireland
Wellington Eye Clinic Recruiting
Dublin, Beacon Court Sandyford, Ireland, 18
Contact: Elizabeth Brennan    353 1 2930470    elizabeth.brennan@wellingtoneyeclinic.com   
Contact: Stephanie Naughton         
Principal Investigator: Arthur Cummings, MD         
Switzerland
Laser Vista Not yet recruiting
Basel, Switzerland, 4051
Contact: Susanne Mueller       Susanne.mueller@vista.ch   
Principal Investigator: Eduard Haefliger, MD         
Sub-Investigator: Thomas Mueller, MD         
Eye Clinic Orasis AG Not yet recruiting
Reinach AG, Switzerland, 5734
Contact: Milena Radoja    +41 62 765 60 80    milena.radoja@orasis.ch   
Principal Investigator: Bojan Pajic, MD         
Sub-Investigator: Brigitte Pajic, MD         
United Kingdom
Corneo Plastic Unit and Eye Bank Queen Victoria Hospital Recruiting
East Grinstead, United Kingdom, RH19 3DZ
Contact: Samer Hamada, MD       corneacare1@gmail.com   
Contact: Debbie Weller    (+44) 01342 414000 ext 4695    debbie.weller@nhs.net   
Principal Investigator: Samer Hamada, MD         
Centre for Sight Recruiting
London, United Kingdom, W1G 8HZ
Contact: Sheraz Daya, MD       sdaya@centreforsight.com   
Principal Investigator: Sheraz Daya, MD         
Optegra Eye Hospital Not yet recruiting
London, United Kingdom
Contact: Paul Rosen, MD         
Principal Investigator: Paul Rosen, MD         
Sponsors and Collaborators
Allotex, Inc.
Investigators
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Study Director: Vance Thompson, MD Study Medical Monitor/Consultant

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Responsible Party: Allotex, Inc.
ClinicalTrials.gov Identifier: NCT03671135     History of Changes
Other Study ID Numbers: PRO_010
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allotex, Inc.:
Intrastromal
Corneal Inlay
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases