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

NCT03671135 | Terminated

• 1 other identifier: PRO_010
• Study Type: interventional
• Target: 121
• Locations: 3 countries
• Sites: 4

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.

Conditions

Presbyopia

Keywords

Intrastromal; Corneal Inlay

Outcome Measures

Primary Outcomes (1)

• Assessment of the accuracy and stability of Presbyopic refractive correction following intervention with the Transform™ Corneal Allograft Inlay.

  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.

  6 months

Study Arms (1)

TCA Intrastromal Inlay

EXPERIMENTAL

A monocular intrastromal corneal inlay will be implanted.

Other: TCA Intrastromal Inlay

Interventions

TCA Intrastromal Inlay OTHER

Anterior surface of Bowmans Layer Corneal Optical Correction Inlay

TCA Intrastromal Inlay

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allotex, Inc.: lead

Study Sites (4)

Medipolis Wilrijk

Antwerp, Boomsesteenweg 223, B-2610, Belgium

Location

Wellington Eye Clinic

Dublin, Beacon Court Sandyford, 18, Ireland

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

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Vance Thompson, 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: August 9, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

IE (1); GB (2); BE (1)