To Study the Effects of Refractive Surgery on OCT Measurements in the Eye
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorUniversity of Nebraska
About this trial
Corrective eye surgeries, such as Lasik, are widely used to correct focusing problems such as myopia, or nearsightedness. Often these patients develop other conditions like myopic maculopathy or glaucoma which require monitoring with optical coherence tomography (OCT). Since OCT is a light-based test and changes the refractive status of the eye (in the cornea or the lens), it can potentially affect the results of the OCT measurements but has not been sufficiently studied. This pilot study aims at studying the potential change in OCT parameters in the eye after undergoing such surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing refractive surgery
For patients undergoing bilateral eye surgery, the one with higher degree of ametropia will be included.
Disqualifiers
Astigmatism more than 3 Diopters
Visual acuity worse than 20/25
Patients with unstable visual fixation
Severe Dry Eye
Trial population
All subjects in the study will be adults aged 19 years or more, that fits the typical age profile of patients in the refractive surgery clinic. Refractive surgery is an elective surgery and the patients are encouraged to ask questions about the study. This is an observational study and all aspects of care, including procedures, visits, and exams, carried out as part of the study represent standard of care. Patients visiting the refractive surgery clinic will be given an option to participate in the study if they meet the selection criteria. The clinical care of the patient will not be affected by the patient's participation or non-participation in the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Optical coherence tomography
Diagnostic testPosterior segment OCT (a non-contact procedure performed over one minute) is additionally performed for patients participating in this study. Proportion of change in measurements in microns will be analyzed.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Ocular parameters1 intervention
Trial outcomes
Primary outcomes
1
Macular thickness
Proportion of Change in thickness of retina and its layers measured in microns
Time frame
1 day after refractive procedure2
Macular thickness
Proportion of Change in thickness of retina and its layers measured in microns
Time frame
1 week after refractive procedureSecondary outcomes
1
Choroidal thickness
Proportion of Change in thickness of choroid and its layers measured in microns
Time frame
1 day after refractive procedure2
Choroidal thickness
Proportion of Change in thickness of choroid and its layers measured in microns
Time frame
1 week after refractive procedure3
visual acuity
Proportion of Change in clarity of vision, measured in logarithm of Minimal Angle of Resolution (logMAR) units
Time frame
1 day after refractive procedure4
visual acuity
Proportion of Change in clarity of vision, measured in logarithm of Minimal Angle of Resolution (logMAR) units
Time frame
1 week after refractive procedureSponsors and contacts
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Source ClinicalTrials.gov