A Phase 2 interventional study of PXL 330 Platinum device/Riboflavin in Keratoconus, Unstable, Ectasia Corneal and Bacterial Keratitis, sponsored by Eye Specialists of Indiana. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by Eye Specialists of Indiana · Phase 2, Interventional, and Treatment
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Among 23 studies testing riboflavin in Keratoconus — 5 open to participants now, 8 under way, 7 of them phase 3. Riboflavin · Keratoconus.
Among the 23 studies testing riboflavin in Keratoconus, this one is the 22nd largest by enrollment, is the only one that started in 2020, is one of 3 in phase 2, and was the 19th registered.
313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
Browse Keratoconus studies →5 of the 23 studies testing riboflavin in Keratoconus are open now, in 1 country. Recruiting first, the newest first:
Price Vision Group · Sites in United States
Ages 10–90
Cornea and Laser Eye Institute · Sites in United States
Ages 18+ · Healthy volunteers
Cornea and Laser Eye Institute · Sites in United States
Ages 12+ · Healthy volunteers
Cornea and Laser Eye Institute · Sites in United States
Ages 12+ · Healthy volunteers
Kent Wellish MD
Ages 12+
By country, each count listing its studies:
Riboflavin: first FDA approval 1953 (M.V.I.-12 ADULT). What it is approved for, and how studies give it, is on its page →
Of the 37 Keratoconus studies recruiting now, 21 (57%) set no upper age limit and 11 (30%) stop at 75 or younger; 17 take children under 18; 15 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 7 · Phase 3 16 · Phase 4 1
First in 2008; this study’s year is marked.
This study's enrollment of 12 is below the median of 40 across 205 interventional studies indexed under Keratoconus.
Median enrollment 170 across the 23 interventional studies. Of the 10 that completed or were terminated, 2 (20%) have results posted.
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8 of 23 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Eye Specialists of Indiana as lead sponsor.
Eye Specialists of Indiana has 1 study filed under Keratoconus — fewer than ten, so there is no comparison to draw.
1 of the studies testing riboflavin in Keratoconus that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04731727Kent Wellish MDTreating Corneal Thinning Conditions With CCL Vario Riboflavin (CXL) | 2026-12 |
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Among the 23 studies testing riboflavin in Keratoconus, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To determine whether the Peschke PXL-330 is safe and effective in the treatment of corneal thinning conditions.
Patients with progressive keratoconus, pellucid marginal degeneration, infectious keratitis, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, intraocular pressure and visual function questionnaire.
Inclusion Criteria:Criterion 1,2,3 are required for all participants. Participants must also meet one or more of criteria 4-12. Criteria 13 is only relevant for contact lens wearers.
Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as
Contact lens wearers only:
Contact Lens Type Discontinuations Time: Soft, 1 week; Soft Extended Wear, 2 weeks; Soft Toric, 3 weeks; Rigid Gas Permeable, 2 weeks per decade of wear -
Exclusion Criteria:
Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
Patients with a current condition that, in the physician's opinion, wold interfere with or prolong epithelial healing.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
30mW, 5 sec, 5 sec off, 10 minutes of illumination. Combination Product: PXL-330 Platinum device for cross linking with Peschke riboflavin solution will be used to load the cornea followed by UV-A cross linking of the cornea
Combination Product: PXL 330 Platinum device/Riboflavin
9mW continuous, 10 minutes of illumination. Combination Product: PXL-330 Platinum device for cross linking with Peschke riboflavin solution will be used to load the cornea followed by UV-A cross linking of the cornea
Combination Product: PXL 330 Platinum device/Riboflavin
Drug page: Riboflavin
30mW, 5 sec, 5 sec off, 10 minutes of illumination
Mean keratometry in diopters
Average keratometry across the anterior topography of the cornea computed by a validated Scheimpflug topographer
Time frame: 1 year
Best corrected visual acuity
Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2020 to primary completion in Aug 2024, 51 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Riboflavin