A Study to Assess Brillouin Hydration Mapping for the Evaluation of Ocular Tissues and Diseases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-79
SponsorMassachusetts General Hospital

About this trial

The overall goal of this study is to develop Brillouin microscope as a novel tool for measuring biomechanical and hydration properties of human tissues in vivo.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy volunteers with normal eyes

Visual acuity between +2 to -6 diopters

Disqualifiers

History of refractive or cataract surgery

History of ocular disease

Active non-ophthalmic systemic disease

Trial population

Aim 1 - Control Group (Healthy Subjects) : 10 subjects per 6 age ranges (20-29yr, 30-39yr, 40-49yr, 50-59yr, 60-69yr, 70-79yr), total 60 subjects Aim 2 - Patient Groups : 20 patients per 6 diseases (Moderate Fuchs' endothelial dystrophy, Early-stage isolated corneal guttae, Primary open-angle glaucoma, Dry eye disease, Keratoconus, post-LASIK), total 120 patients.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 2 trial groups
Group A: Control Group
Group B: Patient Group

Trial outcomes

Primary outcomes

1

Number of subjects to successfully complete Brillouin measurement without serious unanticipated adverse events related to application of the device.

Number and percentage of enrolled subjects who complete the single Brillouin imaging session without experiencing a serious unanticipated adverse event related to the investigational Brillouin Ocular Scanner, as determined by study staff monitoring during and immediately following the imaging procedure.

Time frame
Through completion of the single study visit, approximately 1-2 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Massachusetts Eye and Ear Infirmary

Collaborator

National Eye Institute (NEI)

Collaborator