HyperopiaNCT03671096
Safety and Efficacy of the Transform™ Corneal Allograft for Hyperopia Correction
A study testing Intrastromal TCA Inlay in people with Hyperopia, run by Allotex, Inc. at 11 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperopia
- What is being tested?
- Intrastromal TCA Inlay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 11 sitesin 6 countries
- Study dates
- Oct 2018to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
United Kingdom3 sites
Corneo Plastic Unit and Eye Bank Queen Victoria Hospital
East Grinstead, RH19 3DZ
Optegra Eye Hospital
London, Marylebone, W1G 9HT
Centre for Sight
London, W1G 8HZ
Austria2 sites
Gemini Augenlaser Wien
Vienna, Opernring 1, 1010
Sekhraft Augenzentrum Wien
Vienna, 1010
France2 sites
Institute Laser Vision Noemie de Rothschild, Fondation Ophthalmolique Adolphe de Rothschild
Paris, 75019
Hospital Pierre Paul Riquet
Toulouse, Purpan, 31300
Switzerland2 sites
Laser Vista
Basel, 4051
Eye Clinic Orasis AG
Reinach, 5734
About this study
Official title: A Prospective Multi Center Clinical Study to Evaluate the Safety And Effectiveness of the Transform™ Corneal Allograft (TCA) for Treatment of Hyperopia
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.
Read the 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.
- Conditions
- Hyperopia
- Being tested
- Intrastromal TCA Inlay
- Keywords
- Intrastromal, Corneal, Allograft
- Medical subject headings
- Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrastromal TCA InlayOther
An intrastromal inlay that will be provided to correct the required hyperopic correction
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Intrastromal TCA Inlay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study startOct 2018 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Why it stopped: The sponsor determined at one study (PRO-010) was sufficient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allotex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Slade, MD, Study director, Study Medical Monitor/Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671096
- Sponsor's protocol ID
- PRO_012
- Status last verified
- Mar 2020
- First submitted
- 6 Sep 2018
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi Center Clinical Study to Evaluate the Safety And Effectiveness of the Transform™ Corneal Allograft (TCA) for Treatment of Hyperopia
- ClinicalTrials.gov ID
- NCT03671096
- Acronym / sponsor ID
- PRO_012
- Conditions
- Hyperopia
- Keywords
- Intrastromal, Corneal, Allograft
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor determined at one study (PRO-010) was sufficient
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Allotex, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2018 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Intrastromal TCA Inlay | Experimental | Other: Intrastromal TCA InlayImplant Intrastromal TCA using femto-second laser surgery It is expected to be carried out once only during the study duration |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrastromal TCA InlayAn intrastromal inlay that will be provided to correct the required hyperopic correction | Other | Intrastromal TCA Inlay |
Primary outcome
Assessment of the accuracy and stability of hyperopia refractive correction following intervention with the Transform™ Corneal Allograft inlay.
Time frame: 6 months
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Slade, MD study director
Study Medical Monitor/Consultant
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrastromal TCA Inlay in people with Hyperopia, run by Allotex, Inc. at 11 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom, Austria, France, Switzerland, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the accuracy and stability of hyperopia refractive correction following intervention with the Transform™ Corneal Allograft inlay. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.