Intraocular Pressure and PROSE LensNCT04308941
Tonometry Precision and Accuracy During PROSE Scleral Lens Wear: A Pilot Study
A study testing Intraocular pressure in people with Intraocular Pressure and PROSE Lens, run by Boston Sight at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure and PROSE Lens
- What is being tested?
- Intraocular pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2020to 27 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written Informed Consent has been obtained prior to any study-related procedures taking place
- Written documentation has been obtained in accordance with the relevant county and local privacy requirements, where applicable
- Male or female, 18 years of age and older prior to the initial visit
- Is an established wearer of PROSE in both eyes; without fenestrations or channels; with diameter equal to or greater than 18.0 mm
- Upon examination by the investigator, there is adequate exposure of the sclera as required for IOP measurements with the planned device
- In the opinion of the investigator, the subject has the ability to follow study instructions
- In the opinion of the investigator, the subject has the ability to complete all study procedures and visits
Who cannot join
- Is aphakic (i.e., missing their natural lens inside the eye)
- Is currently participating in any other type of eye-related clinical or research study
- Is pregnant or nursing as reported by the subject
- Less than 18 years of age
- Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study
- Has had previous ocular surgery within the past 12 weeks
- Has a diagnosis of glaucoma, glaucoma suspect, ocular hypertension or prior glaucoma surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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:
- Written Informed Consent has been obtained prior to any study-related procedures taking place
- Written documentation has been obtained in accordance with the relevant county and local privacy requirements, where applicable
- Male or female, 18 years of age and older prior to the initial visit
- Is an established wearer of PROSE in both eyes; without fenestrations or channels; with diameter equal to or greater than 18.0 mm
- Upon examination by the investigator, there is adequate exposure of the sclera as required for IOP measurements with the planned device
- In the opinion of the investigator, the subject has the ability to follow study instructions
- In the opinion of the investigator, the subject has the ability to complete all study procedures and visits
The participant would not be eligible to participate if at least one of the following criteria is met:
- Is aphakic (i.e., missing their natural lens inside the eye)
- Is currently participating in any other type of eye-related clinical or research study
- Is pregnant or nursing as reported by the subject
- Less than 18 years of age
- Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study
- Has had previous ocular surgery within the past 12 weeks
- Has a diagnosis of glaucoma, glaucoma suspect, ocular hypertension or prior glaucoma surgery
The following special populations will be excluded from this study:
- Adults unable to consent (including adults unable to read and understand English)
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Employees of BostonSight
Vulnerable Populations
The following special populations will be excluded from this study:
- Adults unable to consent (including adults unable to read and understand English)
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Employees of BostonSight
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):
- Scleral TonoPen
- Scleral pneumatonometry
- Transpalpebral Diaton
- Assess the conjunctiva of both eyes after measurement with the PD on
- Conditions
- Intraocular Pressure and PROSE Lens
- Being tested
- Intraocular pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular pressureDiagnostic test
The intraocular pressure will be measured using one of three devices
| Study group | Role | What they receive |
|---|---|---|
| Scleral Tonopen | Active comparator | The first 10 subjects will be randomly chosen for the first cohort (scleral TonoPen) Receives: Diagnostic Test: Intraocular pressure |
| Scleral Pneumatonometer | Active comparator | The second 10 subjects will be randomly chosen for the second cohort (scleral pneumatonometry) Receives: Diagnostic Test: Intraocular pressure |
| Diaton | Active comparator | The third 10 subjects will be randomly chosen for the third cohort (Diaton). Receives: Diagnostic Test: Intraocular pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Goal of This Research is to Determine the Reproducibility of Measurements of Intraocular Pressure (IOP) When a Scleral Lens is on the Eye.
Intraocular pressure will be measured using one of three different tonometers. The reproducibility of measurements on each device will be studied.
Measured: patient will participate for 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start13 Apr 2020
- Primary completion27 Apr 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intraocular Pressure and PROSE LensStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Sight
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel C Brocks, Boston Sight
- Investigators
- Daniel Brocks, MD, Principal investigator, Boston Sight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308941
- Sponsor's protocol ID
- BFS-KR-IOP-02
- Status last verified
- Oct 2023
- First submitted
- 12 Mar 2020
- Last updated
- 9 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We do not anticipate the need to share but will publish findings
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tonometry Precision and Accuracy During PROSE Scleral Lens Wear: A Pilot Study
- ClinicalTrials.gov ID
- NCT04308941
- Acronym / sponsor ID
- BFS-KR-IOP-02
- Conditions
- Intraocular Pressure and PROSE Lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boston SightUniversity, hospital or other
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Posted 9 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Written Informed Consent has been obtained prior to any study-related procedures taking place
- Written documentation has been obtained in accordance with the relevant county and local privacy requirements, where applicable
- Male or female, 18 years of age and older prior to the initial visit
- Is an established wearer of PROSE in both eyes; without fenestrations or channels; with diameter equal to or greater than 18.0 mm
- Upon examination by the investigator, there is adequate exposure of the sclera as required for IOP measurements with the planned device
- In the opinion of the investigator, the subject has the ability to follow study instructions
- In the opinion of the investigator, the subject has the ability to complete all study procedures and visits
The participant would not be eligible to participate if at least one of the following criteria is met:
- Is aphakic (i.e., missing their natural lens inside the eye)
- Is currently participating in any other type of eye-related clinical or research study
- Is pregnant or nursing as reported by the subject
- Less than 18 years of age
- Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study
- Has had previous ocular surgery within the past 12 weeks
- Has a diagnosis of glaucoma, glaucoma suspect, ocular hypertension or prior glaucoma surgery
The following special populations will be excluded from this study:
- Adults unable to consent (including adults unable to read and understand English)
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Employees of BostonSight
Vulnerable Populations
The following special populations will be excluded from this study:
- Adults unable to consent (including adults unable to read and understand English)
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Employees of BostonSight
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):
- Scleral TonoPen
- Scleral pneumatonometry
- Transpalpebral Diaton
- Assess the conjunctiva of both eyes after measurement with the PD on
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Scleral Tonopen | Active comparator | Diagnostic Test: Intraocular pressureThe first 10 subjects will be randomly chosen for the first cohort (scleral TonoPen) |
| Scleral Pneumatonometer | Active comparator | Diagnostic Test: Intraocular pressureThe second 10 subjects will be randomly chosen for the second cohort (scleral pneumatonometry) |
| Diaton | Active comparator | Diagnostic Test: Intraocular pressureThe third 10 subjects will be randomly chosen for the third cohort (Diaton). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written Informed Consent has been obtained prior to any study-related procedures taking place
- Written documentation has been obtained in accordance with the relevant county and local privacy requirements, where applicable
- Male or female, 18 years of age and older prior to the initial visit
- Is an established wearer of PROSE in both eyes; without fenestrations or channels; with diameter equal to or greater than 18.0 mm
- Upon examination by the investigator, there is adequate exposure of the sclera as required for IOP measurements with the planned device
Key exclusion criteria (7 listed)
- Is aphakic (i.e., missing their natural lens inside the eye)
- Is currently participating in any other type of eye-related clinical or research study
- Is pregnant or nursing as reported by the subject
- Less than 18 years of age
- Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraocular pressureThe intraocular pressure will be measured using one of three devices | Diagnostic test | Diaton, Scleral Pneumatonometer, Scleral Tonopen |
Primary outcome
The Goal of This Research is to Determine the Reproducibility of Measurements of Intraocular Pressure (IOP) When a Scleral Lens is on the Eye.
Time frame: patient will participate for 1 hour
Intraocular pressure will be measured using one of three different tonometers. The reproducibility of measurements on each device will be studied.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We do not anticipate the need to share but will publish findings
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Brocks, MD principal investigator
Boston Sight
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular pressure in people with Intraocular Pressure and PROSE Lens, run by Boston Sight at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Goal of This Research is to Determine the Reproducibility of Measurements of Intraocular Pressure (IOP) When a Scleral Lens is on the Eye. (time frame: patient will participate for 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.