HyperopiaNCT03805425
PiXL for Correction of Hyperopia
A study testing PiXL in people with Hyperopia, run by Gemini Eye Clinic at 1 site in Czechia.
Trial summary
This clinical study aims to investigate the efficacy and safety of PiXL in the refractive correction of low hyperopia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperopia
- What is being tested?
- PiXL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCzechia
- Study dates
- Dec 2016to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- low hyperopia of spherical equivalent from +0.5 up to +1.75 D sp. eq.
- astigmatism up to 0.75 Dcyl
- corneal thickness above 400 µm
- endothelial cell density above 1500 cell/mm2
Who cannot join
- any prior corneal surgery or any eye surgery within the last 3 months,
- any corneal pathology e.g. corneal scar or dystrophy
- unstable refraction
- patient not able to understand and sign informed consent
- patients with connective tissue disorder or uncontrolled diabetes
- pregnant or lactating women
- aphakic eyes or pseudophakic eyes without UV blocking IOL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Photorefractive Intrastromal Corneal Crosslinking (PiXL) for Correction of Hyperopia
This clinical study aims to investigate the efficacy and safety of PiXL in the refractive correction of low hyperopia.
Read the detailed description
This clinical study aims to investigate the efficacy and safety of PiXL in the refractive correction of low hyperopia.Slightly modified settings from previously published study is applied to eyes with low hyperopia with an expected refractive change of 0.75 D. Aim is to evaluate the refractive outcome of this procedure.
- Conditions
- Hyperopia
- Being tested
- PiXL
- Keywords
- Hypeorpia, Crosslinking, PiXL
- Medical subject headings
- Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiXLRadiation
The system is set to deliver 30 mW/cm2 UVA irradiance in pulsed intervals of 1 second on and 1 second off to 5 to 9 mm diameter corneal annulus. Total energy delivered is 15J.
| Study group | Role | What they receive |
|---|---|---|
| Photorefractive intrastromal corneal crosslinking (PiXL) | Experimental | Patients undergo PiXL where the UVA light is delivered in customized patterns and corneal changes are achieved. For hyperopia, a ring shape irradiation is used to steepen the central cornea. An oxygen mask is used to enhance the crosslinking efficacy. A dedicated riboflavin formulation penetrates the corneal stroma. Pulsed UVA light with oxygen triggers the covalent bonds of collagen strands in riboflavin soaked cornea. Receives: Radiation: PiXL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Uncorrected Distance Visual Acuity
Best distance visual acuity tested without any correction
Measured: Month 12
Change in Subjective Refraction
Spherical and cylindrical correction
Measured: Month 12
Secondary outcomes (6)
Change in keratometry
Change in keratomery parameter K2-K1provided by Pentacam
Measured: Month 12
Change in Higher Order Aberrations
Higher Order Aberrations assessed using Pentacam
Measured: Month 12
Change in pachymetry
Change in mean cornea thickness in 8.0 mm ring provided by Pentacam
Measured: Month 12
Subjective questionnaire score
Questionnaire assessing participants discomfort at 6 months in respect to their photophobia, pain and dry eye.
Measured: Month 12
Change in Corrected Distance Visual Acuity
Best distance visual acuity tested with the best correction
Measured: Month 12
Change in Spherical aberration
Spherical aberration assessed using Pentacam
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study startDec 2016
- Primary completionDec 2020
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gemini Eye Clinic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pavel Stodulka, MD, PhD, Principal investigator, Gemini Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805425
- Sponsor's protocol ID
- PiXLHyperopia
- Status last verified
- May 2019
- First submitted
- 10 Jan 2019
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kanellopoulos AJ, Asimellis G. Hyperopic correction: clinical validation with epithelium-on and epithelium-off protocols, using variable fluence and topographically customized collagen corneal crosslinking. Clin Ophthalmol. 2014 Dec 2;8:2425-33. doi: 10.2147/OPTH.S68222. eCollection 2014.
PubMed 25506204
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photorefractive Intrastromal Corneal Crosslinking (PiXL) for Correction of Hyperopia
- ClinicalTrials.gov ID
- NCT03805425
- Acronym / sponsor ID
- PiXLHyperopia
- Conditions
- Hyperopia
- Keywords
- Hypeorpia, Crosslinking, PiXL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Gemini Eye ClinicIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Mar 2021 (estimated)
- First posted
- 15 Jan 2019 (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.
This clinical study aims to investigate the efficacy and safety of PiXL in the refractive correction of low hyperopia.
Detailed description
This clinical study aims to investigate the efficacy and safety of PiXL in the refractive correction of low hyperopia.Slightly modified settings from previously published study is applied to eyes with low hyperopia with an expected refractive change of 0.75 D. Aim is to evaluate the refractive outcome of this procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photorefractive intrastromal corneal crosslinking (PiXL) | Experimental | Radiation: PiXLPatients undergo PiXL where the UVA light is delivered in customized patterns and corneal changes are achieved. For hyperopia, a ring shape irradiation is used to steepen the central cornea. An oxygen mask is used to enhance the crosslinking efficacy. A dedicated riboflavin formulation penetrates the corneal stroma. Pulsed UVA light with oxygen triggers the covalent bonds of collagen strands in riboflavin soaked cornea. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- low hyperopia of spherical equivalent from +0.5 up to +1.75 D sp. eq.
- astigmatism up to 0.75 Dcyl
- corneal thickness above 400 µm
- endothelial cell density above 1500 cell/mm2
Key exclusion criteria (7 listed)
- any prior corneal surgery or any eye surgery within the last 3 months,
- any corneal pathology e.g. corneal scar or dystrophy
- unstable refraction
- patient not able to understand and sign informed consent
- patients with connective tissue disorder or uncontrolled diabetes
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 |
|---|---|---|
| PiXLThe system is set to deliver 30 mW/cm2 UVA irradiance in pulsed intervals of 1 second on and 1 second off to 5 to 9 mm diameter corneal annulus. Total energy delivered is 15J. | Radiation | Photorefractive intrastromal corneal crosslinking (PiXL) |
Primary outcome
Change in Uncorrected Distance Visual Acuity
Time frame: Month 12
Best distance visual acuity tested without any correction
Change in Subjective Refraction
Time frame: Month 12
Spherical and cylindrical correction
6 secondary outcomes
Change in keratometry
Time frame: Month 12
Change in Higher Order Aberrations
Time frame: Month 12
Change in pachymetry
Time frame: Month 12
Subjective questionnaire score
Time frame: Month 12
Change in Corrected Distance Visual Acuity
Time frame: Month 12
Change in Spherical aberration
Time frame: Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Background: PubMed 25506204Kanellopoulos AJ, Asimellis G. Hyperopic correction: clinical validation with epithelium-on and epithelium-off protocols, using variable fluence and topographically customized collagen corneal crosslinking. Clin Ophthalmol. 2014 Dec 2;8:2425-33. doi: 10.2147/OPTH.S68222. eCollection 2014.
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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.
Pavel Stodulka, MD, PhD principal investigator
Gemini Eye Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PiXL in people with Hyperopia, run by Gemini Eye Clinic at 1 site in Czechia.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Feb 2021. 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 Czechia. 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?
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?
Change in Uncorrected Distance Visual Acuity (time frame: Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03805425, which also lists 1 linked publication.
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 3 Feb 2021.