Actively Recruiting

Age: 14Years - 85Years
All Genders
Healthy Volunteers
ID03504800

Optical Coherence Tomography-Aided Diagnosis and Treatment of Irregular Corneas

Led by Oregon Health and Science University · Updated on 2025-09-09

445

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying ways to better detect, classify, monitor, and treat irregular corneas caused by conditions such as keratoconus, corneal warpage from contact lenses, dry eye, scars, stromal dystrophies, and other corneal issues. The study aims to improve diagnosis and treatment by using optical coherence tomography (OCT), a detailed imaging technique, to develop systems for classifying corneal irregularities, detecting keratoconus progression, and guiding phototherapeutic keratectomy (PTK) for corneal irregularities. Participants aged 14 to 85 with various corneal irregularities will be included in Group A, whose data will be compared to healthy controls. From Group A, those diagnosed with keratoconus will be followed for up to 4 years to monitor disease progression in Group B. Participants with vision limited by scars, dystrophy, or high astigmatism who may benefit from PTK will be followed for up to 1 year in Group C. OCT will be used to classify irregularities and select participants for these groups. During the study, participants in Group A have one data collection visit, while Groups B and C have follow-up visits lasting up to 4 years and 1 year, respectively. Researchers will use OCT imaging and topography to assess corneal shape and disease progression, as well as guide treatment planning. The study will measure the development of OCT-based metrics for classification, detection of keratoconus progression, and OCT-guided PTK outcomes. Participants' vision and corneal condition will be monitored regularly to evaluate these new diagnostic and treatment methods.

CONDITIONS

Brief Title

OCT in Diagnosis of Irregular Corneas

Who Can Participate

Age: 14Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 14 to 85 years
  • Diagnosis or symptoms of keratoconus, contact lens-related corneal warpage, dry eye, epithelial basement membrane dystrophy, stromal scars, dystrophies, or corneal transplants
  • Healthy controls with no previous eye procedures or surgeries
  • Ability to provide informed consent
  • Ability to maintain eye fixation for OCT imaging
  • Commitment to required study visits
Not Eligible

You will not qualify if you...

  • Inability to give informed consent
  • Inability to maintain fixation for OCT imaging
  • Inability to commit to required study visits
  • Presence of cataract, retinal disease, glaucoma, or other eye conditions that may limit vision after surgery
  • Previous corneal surgeries if considered as a keratoconus participant
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo Optical Coherence Tomography (OCT) to classify corneal irregularities and determine group assignment.

1 visit (in-person)

Surveillance

Duration - Up to 4 years

Participants diagnosed with keratoconus are monitored for disease progression over time.

Regular visits during follow-up up to 4 years

Treatment

Duration - Up to 1 year

Participants with vision limitations due to scars, dystrophy, or high astigmatism receive OCT- and topography-guided phototherapeutic keratectomy (PTK) intervention and follow-up.

Follow-up visits during 1 year post-treatment

Trial Site Locations

Total: 1 location

1

Humberto Martinez

Portland, Oregon, United States, 97239

Actively Recruiting

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Research Team

H

Humberto Martinez, COT

D

Denny Romfh, OD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Frequently Asked Questions

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