PresbyopiaNCT03671135
Safety and Efficacy of an Intrastromal Transform™ Corneal Allograft (TCA) for Presbyopia Correction
A study testing TCA Intrastromal Inlay in people with Presbyopia, run by Allotex, Inc. at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- TCA Intrastromal Inlay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 9 Aug 2018to 31 Dec 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
4 sites in 3 countries.
4 sites in 3 countries
United Kingdom2 sites
Corneo Plastic Unit and Eye Bank Queen Victoria Hospital
East Grinstead, RH19 3DZ
Centre for Sight
London, W1G 8HZ
About this study
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
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.
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 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.
- Conditions
- Presbyopia
- Being tested
- TCA Intrastromal Inlay
- Keywords
- Intrastromal, Corneal Inlay
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCA Intrastromal InlayOther
Anterior surface of Bowmans Layer Corneal Optical Correction Inlay
| Study group | Role | What they receive |
|---|---|---|
| TCA Intrastromal Inlay | Experimental | A monocular intrastromal corneal inlay will be implanted. Receives: Other: TCA Intrastromal 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 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.
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 start9 Aug 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: COVID-19
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
- Model description
- Single group assignment
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allotex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vance Thompson, MD, Study director, Study Medical Monitor/Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671135
- Sponsor's protocol ID
- PRO_010
- Status last verified
- Feb 2024
- First submitted
- 6 Sep 2018
- Last updated
- 23 Feb 2024
- 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 23 Feb 2024. 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 Intrastromal Implant of the Transform Corneal Allograft (TCA) for Providing Near Vision in Presbyopic Subjects
- ClinicalTrials.gov ID
- NCT03671135
- Acronym / sponsor ID
- PRO_010
- Conditions
- Presbyopia
- Keywords
- Intrastromal, Corneal Inlay
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Allotex, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- 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 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 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.
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 |
|---|---|---|
| TCA Intrastromal Inlay | Experimental | Other: TCA Intrastromal InlayA monocular intrastromal corneal inlay will be implanted. |
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 |
|---|---|---|
| TCA Intrastromal InlayAnterior surface of Bowmans Layer Corneal Optical Correction Inlay | Other | TCA Intrastromal Inlay |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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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.
Vance Thompson, MD study director
Study Medical Monitor/Consultant
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCA Intrastromal Inlay in people with Presbyopia, run by Allotex, Inc. at 4 sites in 3 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: stopped early, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Belgium, Ireland. 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 stopped early (reason given: COVID-19). Results are not available in the source record.
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 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 23 Feb 2024.