Tonometry Precision and Accuracy During PROSE Scleral Lens Wear: A Pilot Study

NCT04308941 | Completed Results FDA Device

• 1 other identifier: BFS-KR-IOP-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Intraocular Pressure and PROSE Lens

Outcome Measures

Primary Outcomes (1)

• 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.

  patient will participate for 1 hour

Study Arms (3)

Scleral Tonopen

ACTIVE COMPARATOR

The first 10 subjects will be randomly chosen for the first cohort (scleral TonoPen)

Diagnostic Test: Intraocular pressure

Scleral Pneumatonometer

ACTIVE COMPARATOR

The second 10 subjects will be randomly chosen for the second cohort (scleral pneumatonometry)

Diagnostic Test: Intraocular pressure

Diaton

ACTIVE COMPARATOR

The third 10 subjects will be randomly chosen for the third cohort (Diaton).

Diagnostic Test: Intraocular pressure

Interventions

Intraocular pressure DIAGNOSTIC_TEST

The intraocular pressure will be measured using one of three devices

Diaton; Scleral Pneumatonometer; Scleral Tonopen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Sight: lead

Study Sites (1)

BostonSight

Needham, Massachusetts, 02494, United States

Location

MeSH Terms

Interventions

Intraocular Pressure

Intervention Hierarchy (Ancestors)

Ocular Physiological Phenomena

Results Point of Contact

• Title: Dr. Daniel Brocks
• Organization: BostonSight

ecrowley@bostonsight.org

(781) 726-7506

Study Officials

• Daniel Brocks, MD

  Boston Sight

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Subjects will be enrolled in each cohort sequentially there is no masking of procedures
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Invesigator

Model Details: 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).

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 16, 2020
• Study Start: April 13, 2020
• Primary Completion: April 27, 2021
• Study Completion: April 27, 2021
• Last Updated: November 9, 2023
• Results First Posted: November 9, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)