Intraocular Pressure Clinical Trial
Official title:
Intraocular Pressure Data Collection With Tonometers
The goal of this clinical trial is to collect a comprehensive dataset of intraocular pressure values for developing a measurement algorithm for the new hand-held rebound tonometer device. The measurement algorithm shall fulfill the requirements of ANSI Z80.10:2014 standard. The study population is adults (age ≥ 18 years). The intraocular pressure of the participants will be measured with four different tonometers.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | September 30, 2024 |
| Est. primary completion date | September 30, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Age = 18 years Exclusion Criteria: - Subjects with only one functional eye - Subjects having poor or eccentric fixation in the study eye(s) - High corneal astigmatism >3D in the study eye(s) - Central corneal scarring - History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s) - Microphthalmos - Buphthalmos - Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally - Dry eyes (clinically significant) - Lid squeezers - blepharospasm - Nystagmus - Keratoconus - Any other corneal or conjunctival pathology or infection relevant to this study - Cataract Extraction within last 2 months in the study eye(s) |
| Country | Name | City | State |
|---|---|---|---|
| Slovenia | Optika Mesec d.o.o. | Bled | |
| Slovenia | Vid d.o.o. | Kromberk | Nova Gorica |
| Lead Sponsor | Collaborator |
|---|---|
| Icare Finland Oy |
Slovenia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Primary Objective | The primary objective of this study is to measure wide range of IOP values with the new tonometer and three comparator devices. The IOP value's unit of measure will be mmHg. | Through study completion, an average of 4 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03494257 -
Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
|
N/A | |
| Completed |
NCT03016234 -
IOP Changes With Different Anesthetic Agents During Laparoscopic Colorectal Surgery
|
N/A | |
| Completed |
NCT04863209 -
Effect of Osteopathic Techiniques on Intraocular Pressure
|
N/A | |
| Completed |
NCT02646033 -
Quantitative Rise in Intraocular Pressure in Steep Trendelenburg Position
|
||
| Completed |
NCT03139708 -
The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients
|
Phase 1 | |
| Recruiting |
NCT02697825 -
Intraocular Pressure Versus Optic Nerve Sheath Diameter
|
N/A | |
| Completed |
NCT02985567 -
An Observational Study of the Use of Chloral Hydrate for Ophthalmic Procedures in Children
|
N/A | |
| Withdrawn |
NCT00837226 -
Effects of Weight Loss From Bariatric Surgery on Intraocular Pressure (IOP)
|
N/A | |
| Completed |
NCT02136589 -
Effect of NSAID on Travoprost-induced Conjunctival Hyperemia and IOP Reduction in Normal Eyes
|
Phase 4 | |
| Completed |
NCT03123614 -
Loteprednol vs. Prednisolone and Fluorometholone
|
Phase 4 | |
| Completed |
NCT05763056 -
Effects of Intubation on Intra-ocular Pressure and Optic Nerve Sheath Diameter
|
N/A | |
| Completed |
NCT03359200 -
Analysis of the Microbiota in Goldmann Applanation Tonometers at a Reference Service in Goiânia
|
N/A | |
| Withdrawn |
NCT02558309 -
Optic Nerve Head Quantification While Reducing Elevated Intracranial Pressure
|
N/A | |
| Completed |
NCT02816905 -
Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery
|
Phase 4 | |
| Completed |
NCT01786954 -
iCare vs Tonopen vs Goldmann Applanation Post-vitrectomy Surgery
|
N/A | |
| Completed |
NCT00552019 -
Intraocular Pressure (IOP) Assessed by Dynamic Contour Tonometer (DCT) and Goldman Applanation Tonometry (GAT)
|
N/A | |
| Completed |
NCT00428740 -
Long-Term IOP Fluctuation and VF Progression After Triple Procedure
|
N/A | |
| Completed |
NCT04360369 -
Comparison of Intraocular Pressure Measurements Between Reichert Tono-Vera Tonometer and Goldmann Tonometry
|
N/A | |
| Completed |
NCT04521140 -
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery
|
Phase 4 | |
| Completed |
NCT05167773 -
Clinical Study of the Topcon Tonometer TRK-3
|