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Recruiting NCT04439552

NCT04439552 fMRI and IVCM Cornea Microscopy of CXL in Keratoconus

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Clinical Trial Summary
NCT ID NCT04439552
Status Recruiting
Phase
Sponsor Boston Children's Hospital
Condition Pain, Postoperative
Study Type OBSERVATIONAL
Enrollment 60 participants
Start Date 2021-10-04
Primary Completion 2027-08

Eligibility & Interventions

Sex All sexes
Min Age 8 Years
Max Age 35 Years
Study Type OBSERVATIONAL

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 60 participants in total. It began in 2021-10-04 with a primary completion date of 2027-08.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Evaluation of neuroplasticity of pain pathways and corneal afferent nerve regeneration following corneal crosslinking (CXL) in keratoconus patients using fMRI and corneal In Vivo Confocal Microscopy (IVCM).

Eligibility Criteria

Inclusion Criteria: CXL Group * Age 8-35 years * Clinical diagnosis of keratoconus and seeking CXL treatment * English speaking ability sufficient to comprehend consent with parental assistance * MRI compatible * Ability to lie still for an MRI session (60 minutes) Control Group * Age 8-35 years * No diagnosis of keratoconus * English speaking ability sufficient to comprehend consent with parental assistance * MRI compatible * Ability to lie still for an MRI session (60 minutes) Exclusion Criteria (Both Groups): * Claustrophobic * Weight \> 285 lbs (weight limit of the MRI table) * Significant medical history, including: Current DSM-IV-TR axis I psychiatric disorders. Chronic pain Significant head injury Seizures Brain tumor Cerebrovascular accident Neurological disease aside from migraine HIV-AIDs Prescription medication strongly implicated in causing dry eyes * Magnetic implants or metal-containing tattoos on their chest or above * Pregnancy * History of contact lens wear * Any allergic response to a numbing eyedrop in the past

Contact & Investigator

Central Contact

Eric A Moulton, OD PhD

✉ eric.moulton@childrens.harvard.edu

📞 617-919-6827

Principal Investigator

Eric A Moulton, OD PhD

PRINCIPAL INVESTIGATOR

Boston Children's Hospital

Frequently Asked Questions

Who can join the NCT04439552 clinical trial?

This trial is open to participants of all sexes, aged 8 Years or older, up to 35 Years, studying Pain, Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT04439552 currently recruiting?

Yes, NCT04439552 is actively recruiting participants. Contact the research team at eric.moulton@childrens.harvard.edu for enrollment information.

Where is the NCT04439552 trial being conducted?

This trial is being conducted at Boston, United States.

Who is sponsoring the NCT04439552 clinical trial?

NCT04439552 is sponsored by Boston Children's Hospital. The principal investigator is Eric A Moulton, OD PhD at Boston Children's Hospital. The trial plans to enroll 60 participants.

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