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The goal of this research is to determine the reproducibility of measurements of intraocular pressure (IOP) when a scleral lens is on the eye. The PROSE device (PD) is a specialized scleral lens that is filled with preservative-free saline and then applied to the eye in order to treat a variety of ocular conditions. The fit of the PROSE device is optimized to land gently on the conjunctival tissue overlying the sclera while completely vaulting the cornea and limbus without touch.
Because the PROSE device vaults and therefore covers the cornea, measuring IOP during PROSE wear is challenging as traditional techniques rely on corneal contact (i.e. Goldmann tonometry, iCare, pneumatonometry, etc.). Measuring IOP before insertion and after removal of the PROSE device likely does not correspond to the true IOP when the PROSE device is actively on the eye.
This is a prospective study of the reproducibility of three non-traditional means of IOP measurements: scleral tonopen, scleral pneumatonometry, and transpalpebral Diaton tonometer. Evaluating these means of measurements may be important for future studies investigating the effect of PROSE wear on intraocular pressure.
Full description
The goal of this research is to determine the reproducibility of measurements of intraocular pressure (IOP) when a scleral lens is on the eye.
This is a prospective study of the reproducibility of three non-traditional means of IOP measurements: scleral tonopen, scleral pneumatonometry, and transpalpebral Diaton tonometer. Evaluating these means of measurements may be important for future studies investigating the effect of PROSE wear on intraocular pressure.
Inclusion and Exclusion Criteria
The participant will be eligible to participate if the following criteria apply:
The participant would not be eligible to participate if at least one of the following criteria is met:
The following special populations will be excluded from this study:
Vulnerable Populations
The following special populations will be excluded from this study:
Number of Subjects A minimum of 30 subjects will be enrolled in this study with 10 subjects in each of the three cohorts. This is a low risk study. The investigators can expect an approximate 10% drop-out rate, so the investigators will expect to recruit approximately 33 subjects; and the first 30 to be eligible and complete the study will be used for data analysis.
The first 10 subjects will be randomly chosen for the first cohort (scleral TonoPen), the second 10 subjects will be randomly chosen for the second cohort (scleral pneumatonometry), and the third 10 subjects will be randomly chosen for the third cohort (Diaton).
Recruitment Methods Recruitment will begin once IRB approval has been received and will occur through BostonSight. The subject pool will consist of patients who are actively coming through the clinic. The investigators anticipate that all our subjects will be from the current patient population at BostonSight. Patients will be recruited via mailing and/or email and at office visits. If a patient is interested in participating in the study, they will be directed to the principal investigator or the study coordinator who will go over the study and ask the screening questions. If they are eligible based on the screening criteria, they will be invited for participation in the study. If the person calls to learn about the study, the investigator or coordinator will use the outline to determine initial eligibility. Current patients of BostonSight may also be recruited as a result of a search of the patient database. A partial HIPAA waiver is requested to permit the investigators to use the database to identify prospective patients.
The primary endpoints in this study are as follows:
Intraocular pressure
Tonopen, scleral with PD
Pneumatonometer, scleral with PD
Diaton, transpalpebral with PD
Procedures Involved Once a subject has been identified, the initial visit will be scheduled.
During the visit:
Informed consent will be completed
Record the patient's general medical history and habitual contact lens information, including lens design, power, and diameter.
An investigator will conduct visual acuity assessments of both eyes (Snellen).
Assess the fit of the PROSE device via slit lamp assessment of both eyes.
Assess the cornea and conjunctiva of both eyes with the PROSE device on and off.
The investigator will instill one drop of topical anesthetic in both eyes followed by a lubricating preservative-free artificial tear drop, such as Refresh Plus, prior to IOP measurements.
Measure intraocular pressure of both eyes with the PD on via (method depends on which cohort subject is in):
Assess the conjunctiva of both eyes after measurement with the PD on
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30 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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