PresbyopiaNCT07208604
Open Label, Multi-center, Phase I Study of TECLens Quantitative Refractive Crosslinking in Presbyopia-Aged Patients.
A study testing Quantitative refractive crosslinking in people with Presbyopia, run by TECLens, Inc. at 1 site in Philippines.
Trial summary
An 'on-eye' UV delivery system for corneal crosslinking can be used safely and effectively to help free presbyopic patients from the need for reading glasses. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- Quantitative refractive crosslinking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 sitePhilippines
- Study dates
- 30 Sep 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 40-65 years
- Healthy cornea
- Refractive error between +4.0 D and -5.0 D
- Phakic or monofocal pseudophakic (≥6 months post IOL placement)
- Visual acuity correctable by ±0.25 D
Who cannot join
- Corneal dystrophy, scarring, or prior corneal crosslinking
- Astigmatism >1.0 D
- Active ocular infection, inflammation, or uncontrolled dry eye
- Advanced glaucoma or diabetic retinopathy
- History of delayed corneal healing
- Pregnancy, breastfeeding, or planning pregnancy during study period
Show all 9Show fewer
- Certain medications (e.g., isotretinoin)
- Recent participation in other investigational drug/device studies (within 30 days)
- Patients with uncontrolled dry eye or surface disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Philippines1 site
Asian Eye Institute
Makati City, Philippines
Mary Ann Catacutan, 632-8898-2019, mtcatacutan@asianeyeinstitute.com
About this study
Official title: Open Label, Multi-center, Phase I Study of TECLens Corneal Crosslinking System for Correction of Refractive Error in Patients of Presbyopia Age.
An 'on-eye' UV delivery system for corneal crosslinking can be used safely and effectively to help free presbyopic patients from the need for reading glasses.
Read the detailed description
The clinical trial is evaluating the TECLens CXLens Crosslinking System, an investigational treatment using ultraviolet (UV) light (375 nm) with riboflavin (vitamin B2) to strengthen and reshape the cornea. By creating controlled biomechanical changes, this study aims to test whether the cornea can be reshaped to reduce refractive errors such as mild myopia or hyperopia in patients of presbyopic age.
- Conditions
- Presbyopia
- Being tested
- Quantitative refractive crosslinking
- Keywords
- Corneal crosslinking, Presbyopia, Myopia, Hyperopia
- Medical subject headings
- Presbyopia, Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative refractive crosslinkingDevice
Non-invasive corneal cross-linking device delivering controlled UV light through a contact lens platform for biomechanical stabilization of the cornea.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Open label treatment arm Receives: Device: Quantitative refractive crosslinking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce refractive error
Achieve manifest refraction outcome at 3 months post treatment within 0.75D of the pre-planned targeted refraction, in patients aged 40 to 65 years old
Measured: 3-months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start30 Sep 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TECLens, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Robert Ang, MD, Robert Ang, MD - Asian Eye Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208604
- Sponsor's protocol ID
- TEC-006
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Multi-center, Phase I Study of TECLens Corneal Crosslinking System for Correction of Refractive Error in Patients of Presbyopia Age.
- ClinicalTrials.gov ID
- NCT07208604
- Acronym / sponsor ID
- TEC-006
- Conditions
- Presbyopia
- Keywords
- Corneal crosslinking, Presbyopia, Myopia, Hyperopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- TECLens, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Robert Ang, MD, Robert Ang, MD - Asian Eye Institute
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 6 Oct 2025 (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.
An 'on-eye' UV delivery system for corneal crosslinking can be used safely and effectively to help free presbyopic patients from the need for reading glasses.
Detailed description
The clinical trial is evaluating the TECLens CXLens Crosslinking System, an investigational treatment using ultraviolet (UV) light (375 nm) with riboflavin (vitamin B2) to strengthen and reshape the cornea. By creating controlled biomechanical changes, this study aims to test whether the cornea can be reshaped to reduce refractive errors such as mild myopia or hyperopia in patients of presbyopic age.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Quantitative refractive crosslinkingOpen label treatment arm |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 40-65 years
- Healthy cornea
- Refractive error between +4.0 D and -5.0 D
- Phakic or monofocal pseudophakic (≥6 months post IOL placement)
- Visual acuity correctable by ±0.25 D
Key exclusion criteria (9 listed)
- Corneal dystrophy, scarring, or prior corneal crosslinking
- Astigmatism >1.0 D
- Active ocular infection, inflammation, or uncontrolled dry eye
- Advanced glaucoma or diabetic retinopathy
- History of delayed corneal healing
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 |
|---|---|---|
| Quantitative refractive crosslinkingNon-invasive corneal cross-linking device delivering controlled UV light through a contact lens platform for biomechanical stabilization of the cornea. | Device | Treatment Group |
Primary outcome
Reduce refractive error
Time frame: 3-months post procedure
Achieve manifest refraction outcome at 3 months post treatment within 0.75D of the pre-planned targeted refraction, in patients aged 40 to 65 years old
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative refractive crosslinking in people with Presbyopia, run by TECLens, Inc. at 1 site in Philippines.
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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Lopath (919-824-5224, plopath@teclens.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduce refractive error (time frame: 3-months post procedure). 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 6 Oct 2025.