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

NCT03671096 | Withdrawn

• 1 other identifier: PRO_012
• Study Type: interventional
• Target: N/A
• Locations: 6 countries
• Sites: 11

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.

Conditions

Hyperopia

Keywords

Intrastromal; Corneal; Allograft

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Intrastromal TCA Inlay

EXPERIMENTAL

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

Interventions

Intrastromal TCA Inlay OTHER

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

Intrastromal TCA Inlay

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allotex, Inc.: lead

Study Sites (11)

Gemini Augenlaser Wien

Vienna, Opernring 1, 1010, Austria

Location

Sekhraft Augenzentrum Wien

Vienna, 1010, Austria

Location

Medipolis Wilrijk

Antwerp, Boomsesteenweg 223, B-2610, Belgium

Location

Hospital Pierre Paul Riquet

Toulouse, Purpan, 31300, France

Location

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

Paris, 75019, France

Location

Wellington Eye Clinic

Dublin, Beacon Court Sandyford, 18, Ireland

Location

Laser Vista

Basel, 4051, Switzerland

Location

Eye Clinic Orasis AG

Reinach, 5734, Switzerland

Location

Optegra Eye Hospital

London, Marylebone, W1G 9HT, United Kingdom

Location

Corneo Plastic Unit and Eye Bank Queen Victoria Hospital

East Grinstead, RH19 3DZ, United Kingdom

Location

Centre for Sight

London, W1G 8HZ, United Kingdom

Location

MeSH Terms

Conditions

Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Stephen Slade, MD

  Study Medical Monitor/Consultant

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 14, 2018
• Study Start: October 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

IE (1); CH (2); BE (1); AU (2); GB (3); FR (2)