445 Participants Needed

Optical Coherence Tomography for Keratoconus

DR
HM
Overseen ByHumberto Martinez, COT
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Oregon Health and Science University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how doctors identify and treat irregular corneas, which can cause vision issues. Researchers use a technology called OCT (a special scan) to develop better methods for spotting these problems, tracking changes over time, and guiding a treatment called PTK (a laser procedure) for certain corneal conditions. Individuals with conditions like keratoconus (where the cornea bulges), corneal scars, or vision problems after eye surgeries might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in eye care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these methods are safe for detecting and treating corneal irregularities?

Research has shown that OCT-and-topography guided PTK is generally safe for treating corneal conditions. Studies have found that it often reduces corneal irregularities, improving vision for many. For instance, one study found that this treatment improved vision in about two-thirds of patients by smoothing these irregularities.

Regarding safety, another study confirmed that this method is safe and effective for treating scars on the front part of the cornea. The procedure removes or reduces scar tissue without causing significant harm.

Additionally, research supports using an OCT-based system to assess corneal shape irregularities. OCT provides a detailed map of the cornea, aiding in accurate diagnosis and treatment planning. This system is non-invasive, meaning it doesn't require surgery or cause physical harm to the eye.

Overall, the treatments studied have been shown to be safe and well-tolerated, with few reports of side effects. However, as with any medical procedure, discussing potential risks with a healthcare provider is always advisable.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to diagnose and treat irregular corneas, which can lead to conditions like keratoconus. Unlike traditional methods that rely on less precise imaging, the trial uses state-of-the-art Optical Coherence Tomography (OCT) to get a detailed view of the cornea's shape. This allows for more accurate classification of corneal irregularities and sensitive detection of keratoconus progression. Additionally, the OCT-and-topography guided phototherapeutic keratectomy (PTK) offers a customized approach to treating corneal scars, dystrophy, or high astigmatism, potentially improving vision outcomes more effectively than existing treatments. Overall, these advancements could lead to earlier intervention and better-targeted therapies for patients with irregular corneas.

What evidence suggests that this trial's treatments could be effective for corneal irregularities?

This trial will evaluate different approaches using Optical Coherence Tomography (OCT) for managing irregular corneas. Group C participants will receive OCT-and-topography guided phototherapeutic keratectomy (PTK). Research has shown that this method can correct irregular corneas by addressing corneal scars and high astigmatism, resulting in clearer and more stable vision.

Group A will use OCT as a tool for examining and classifying corneal irregularities. It creates detailed maps of the cornea, aiding doctors in accurately assessing and monitoring conditions like keratoconus. This system enhances the ability to track changes in the cornea over time.

Group B will focus on new OCT measurements developed to detect the progression of keratoconus more effectively. These advanced imaging techniques can identify changes earlier, potentially preventing further vision loss. Overall, OCT-based methods have shown promising results in managing and treating irregular corneas.678910

Who Is on the Research Team?

YL

Yan Li, PhD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

Inclusion Criteria

Aqueous deficiency or evaporative dry eye
Negative corneal fluorescein staining;
CDVA ≥ 20/25 in the better eye; and both of the following in the worse eye
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Classification of Corneal Irregularities

Participants' corneal irregularities are classified using OCT and compared against healthy corneas

1 day
1 visit (in-person)

Detection of Keratoconus Progression

Participants diagnosed with keratoconus are monitored for progression using OCT metrics

4 years

OCT-and-Topography Guided PTK

Participants with vision limited by scars, dystrophy, or high astigmatism undergo PTK treatment

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • OCT-and-topography guided phototherapeutic keratectomy (PTK) for irregular corneas
  • OCT-based system to classify and evaluate corneal-shape irregularities
  • OCT metrics for more sensitive detection of keratoconus progression
  • Optical Coherence Tomography
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Group C: OCT-and-Topography Guided PTKExperimental Treatment1 Intervention
Group II: Group B: Detection of Keratoconus ProgressionExperimental Treatment1 Intervention
Group III: Group A: Classification of Corneal IrregularitiesExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials
1,024
Recruited
7,420,000+

Citations

Prediction of keratoconus progression using deep learning ...Deep learning of the As-OCT color-coded maps effectively discriminates progressive keratoconus from non-progressive keratoconus with an accuracy of ...
Identifying, Treating, and Monitoring the Progression of ...Before vision loss has occurred, the most effective way to diagnose keratoconus is with topography; however, in the current care model, many eye care providers ...
Assessment of OCT and Angio-OCT Parameters in ...This study found that the RPC density inside the disc is significantly reduced in keratoconus patients after penetrating keratoplasty.
Establishing the ground truth for keratoconus progression:...All data were obtained using the MS-39 AS-OCT, which uses a combination of spectral domain optical coherence tomography (SD-OCT) and Placido-disc corneal ...
Cochrane corner: artificial intelligence for keratoconus | EyeAI algorithms exhibited an overall high accuracy in detecting manifest keratoconus, with a summary sensitivity of 98.6% (95% CI 97.6–99.1) and specificity of ...
Influence of Keratoconus Severity on Detecting True ...These results show that the greater the keratoconus severity, the greater the change that must occur for it to be considered real.
Efficacy, Safety, and Outcomes following Accelerated and ...The aim of this large retrospective cohort study was to describe outcomes following A-CXL and I-CXL protocols for progressive keratoconus.
AI Model Predicts Keratoconus Progression Risk From Just ...All data came from patients seen for multiple visits at the keratoconus clinic at Moorfields Eye Hospital with at least 90 days between visits ...
Longitudinal assessment of the progression of severe ...Patients with severe KC showed reduced anterior corneal surface curvature and no change in corneal thickness during an average follow-up period ...
Managing Progression in KeratoconusThis guide reviews comprehensive protocols for managing the progression of keratoconus (KC), incorporating aspects of testing, diagnosis, monitoring, and ...
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