CLINICAL TRIAL

Laser Custom Corneal Collagen Cross-Linking for Keratoconus

Recruiting · 18+ · All Sexes · Portland, OR

This study is evaluating whether a new laser treatment for keratoconus will improve vision.

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About the trial for Keratoconus

Treatment Groups

This trial involves 2 different treatments. Laser Custom Corneal Collagen Cross-Linking is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Laser Custom Corneal Collagen Cross-Linking
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Minimum corneal thickness of 410 microns
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 month after the CXL procedure
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 month after the CXL procedure.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Laser Custom Corneal Collagen Cross-Linking will improve 1 primary outcome and 1 secondary outcome in patients with Keratoconus. Measurement will happen over the course of 6 months after the CXL procedure.

Improvement in best spectacle-corrected visual acuity after laser custom CXL
6 MONTHS AFTER THE CXL PROCEDURE
The primary goal of the trial is to determine the extent of visual improvement after laser custom CXL compared to preoperative measurements. Vision will be checked at various time points, but the primary time point will be 6-months post-procedure.
Determine CXL demarcation line depth
1 MONTH AFTER THE CXL PROCEDURE
The study will use OCT imaging to measure the CXL demarcation line inside the entire optical zone. The demarcation line indicates the portion of corneal stroma being cross-linked. This helps determine to what extent the cornea is being strengthened.

Who is running the study

Principal Investigator
D. H.
Prof. David Huang, Peterson Professor of Ophthalmology & Professor of Biomedical Engineering
Oregon Health and Science University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is keratoconus?

Since the disease is rare, there is no standard treatment, and since the disease does not have any known cause, it cannot be fully prevented. Keratoconus is believed to be a primary defect in the cornea and should be treated with respect.

Anonymous Patient Answer

How many people get keratoconus a year in the United States?

Keratoconus is relatively common. In the age group of 10 to 24 years old, there is an average of 1.76 new cases per year per 1000 persons. At that age, 0.47% of patients are considered to be at risk for developing keratoconus. After age 30, the frequency of reporting is significantly lower and the incidence is roughly 1 case per 1000 persons per year.

Anonymous Patient Answer

Does laser custom corneal collagen cross-linking improve quality of life for those with keratoconus?

Corneal LCoCL may be an efficacious, easy-to-implement treatment for keratoconus that can improve QOL. However, long-term follow-up will be required to determine whether this benefit improves QOL over the long term.

Anonymous Patient Answer

What are the signs of keratoconus?

Signs of Keratoconus are frequent, varied and can include both clinical features such as the cornea being unusually irregularly astigmatic and ocular surface abnormalities and signs such as the photopsias, visual field defects, and RPE abnormalities. The use of high-resolution corneal confocal microscopy in cases is recommended as being superior to slit-lamp microscopy for making the diagnosis of Keratoconus.

Anonymous Patient Answer

What causes keratoconus?

Although it is not certain what is the exact cause of keratoconus, the exact cause of both keratoconus and Fuchs' corneovascular endothelial dystrophy is unknown. In this case, it is likely that a defect in endothelium as well as vascular dysfunction contributes to both conditions.

Anonymous Patient Answer

Can keratoconus be cured?

The data presented in this study strongly support the assertion that at best, keratoconus does not lead to complete epithelialisation of corneal surface and full healing of corneal tissue must always be considered. Findings from a recent study of this study can therefore be interpreted in a context of the long-term persistence of clinical features of keratoconus even if signs of re-epithelialisation were not observed; it is therefore important to remember that keratoconus cannot be cured. Therefore, treatment of keratoconus cannot be a solution to halt progression of corneal disease in patients with this disease as it is the case for corneal remodelling or keratolysis.

Anonymous Patient Answer

What are common treatments for keratoconus?

Some medications such as NSAIDS can be useful in reducing pain associated with corneal abrasions; however they can make the cornea appear bluer. The topical application of eye drops is an effective method of controlling eye pain when corneal abrasions, particularly eye redness and discharge, may be disabling during sleep. The topical application of steroids may reduce redness and swelling. Some physicians have used a steroid intra-sutural injection for moderate-to-severe disease as a means of reducing the severity of eye pain. However this involves the injection of steroids in a single treatment which can result in devastating side effects.

Anonymous Patient Answer

What are the common side effects of laser custom corneal collagen cross-linking?

The incidence of LASIK complications, including keratocyte loss, was higher in patients who had previous LASIK. Patients who required more than one LASIK procedure were more likely to develop corneal erosion in comparison to those who required only one LASIK procedure.

Anonymous Patient Answer

Who should consider clinical trials for keratoconus?

Most patients will probably not want to participate in a clinical trial to examine the effects of contact lens treatment of keratoconus. This should be regarded as a strong argument against offering clinical trials to patients with keratoconus.

Anonymous Patient Answer

What does laser custom corneal collagen cross-linking usually treat?

Laser custom CXL surgery is a viable option for patients with moderate-to-severe keratoconus and has shown efficacy in providing a significant reduction of corneal astigmatism. Some patients have a significant improvement of visual acuity.

Anonymous Patient Answer

What is the average age someone gets keratoconus?

The average age one gets keratoconus is around 30, but some studies show an increase in keratoconus prevalence with the increase in the age of patients and the increase in the exposure to ultraviolet light. The increase in the exposure to the UV light has been linked to the decrease in vitamin D content of the skin and the consequent increase in the psoriasis. It has been observed that keratoconus is more common in people with psoriasis or vitiligo. The vitiligo and psoriasis may be associated with an inherited predisposition.

Anonymous Patient Answer

What is the primary cause of keratoconus?

I think keratoconus is a condition or disease of one's eyesight. What can be mistaken is that the eyesight itself can vary. There is many things in the eye that will cause problems. The two most important cause are a misalignment of the cornea and a deformity of the cornea's shape. With all of these variables being corrected, you'll still have keratoconus. The eye itself can have a deformity, but the eye itself isn't the problem! It is your eyes looking in a certain way (like an eye that's been hit by a glass breaking into it). The eye's optics are broken.

Anonymous Patient Answer
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