PresbyopiaNCT03675438
Safety and Efficacy of a Sub-epitheilal Transform™ Corneal Allograft (TCA) for Presbyopia Correction
A study testing Sub-epitheilal TCA Inlay in people with Presbyopia and Refractive Errors, 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 subepithelial implantation of the Allotex TransForm corneal allograft (TCA) for improving near vision in presbyopic subjects. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Presbyopia, Refractive Errors
- What is being tested?
- Sub-epitheilal 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
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 Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Subepithelial Implantation of the Transform Corneal Allograft (TCA) for Improving Near Vision in Presbyopic Subjects
The objective of this clinical study is to evaluate the safety and effectiveness of subepithelial implantation of the Allotex TransForm corneal allograft (TCA) for improving near vision in presbyopic subjects.
Read the 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 applied to the surface of Bowman's membrane just underneath the epithelium. 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.
- Conditions
- Presbyopia, Refractive Errors
- Being tested
- Sub-epitheilal TCA Inlay
- Medical subject headings
- Presbyopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-epitheilal TCA InlayOther
A TCA lenticule is placed at the sub-epithelial interface with the anterior surface of Bowmans layer
| Study group | Role | What they receive |
|---|---|---|
| Sub-epitheilal TCA Inlay | Experimental | Implantation of a sub-epithelial presbyopia corrective inlay using TCA technology Receives: Other: Sub-epitheilal 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 Presbyopic refractive management following intervention with the Transform™ Corneal Allograft inlay.
Improvement in uncorrected near visual acuity (at 40 cm) post-operatively to 20/40 or better.
Measured: 6 months
Secondary outcomes (1)
Assessment of the overall patient population achieving Primary Outcome 1
More than 65% of eyes should have an uncorrected near visual acuity of 20/40 or better.
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 posted18 Sep 2018
- Study startOct 2018 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Why it stopped: The sponsor determined that 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 PresbyopiaStudies 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
- 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
- Peter Hersh, MD, Study director, Study Medical Monitor/Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675438
- Sponsor's protocol ID
- PRO_011
- 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 Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Subepithelial Implantation of the Transform Corneal Allograft (TCA) for Improving Near Vision in Presbyopic Subjects
- ClinicalTrials.gov ID
- NCT03675438
- Acronym / sponsor ID
- PRO_011
- Conditions
- Presbyopia, Refractive Errors
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor determined that 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
- 18 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 subepithelial implantation of the Allotex TransForm corneal allograft (TCA) for improving near vision in presbyopic subjects.
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 applied to the surface of Bowman's membrane just underneath the epithelium. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sub-epitheilal TCA Inlay | Experimental | Other: Sub-epitheilal TCA InlayImplantation of a sub-epithelial presbyopia corrective inlay using TCA technology |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
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 |
|---|---|---|
| Sub-epitheilal TCA InlayA TCA lenticule is placed at the sub-epithelial interface with the anterior surface of Bowmans layer | Other | Sub-epitheilal TCA Inlay |
Primary outcome
Assessment of the accuracy and stability of Presbyopic refractive management following intervention with the Transform™ Corneal Allograft inlay.
Time frame: 6 months
Improvement in uncorrected near visual acuity (at 40 cm) post-operatively to 20/40 or better.
1 secondary outcome
Assessment of the overall patient population achieving Primary Outcome 1
Time frame: 6 months
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.
Peter Hersh, 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 Sub-epitheilal TCA Inlay in people with Presbyopia and Refractive Errors, 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 16 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 Presbyopic refractive management 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.