Anesthesia-Free Tonometer Tips for Glaucoma

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Duke University

Disqualifiers: Corneal scarring, Eye infection, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare the tolerability and comfort of 3 different prototype anesthesia-free tonometer tips with the standard tonometer tip in conjunction with anesthesia. The best-tolerated prototype anesthesia-free tonometer tip will be identified for further development for home tonometry.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Anesthesia-Free Tonometer Tips for Glaucoma is an effective treatment?

The available research shows that Anesthesia-Free Tonometer Tips, like the non-contact tonometer, are effective for measuring eye pressure in normal ranges without needing anesthesia. This avoids risks like eye scratches and infections. However, they are less reliable for high pressure readings compared to the Goldmann tonometer. The rebound tonometer is noted for its accuracy, especially when compared to other methods. Overall, these tools are useful for regular checks and screenings, but may not be as effective for more severe cases. ^{1 2 3 4 5}

What safety data exists for anesthesia-free tonometer tips for glaucoma?

The safety data for anesthesia-free tonometer tips, such as the Rebound tonometer and Non-contact Air-puff tonometer, indicate they are generally well-tolerated and effective for measuring intraocular pressure without anesthesia. Studies have shown that these devices are patient-friendly, provide rapid and accurate measurements, and are comparable to the Goldmann applanation tonometer, which is the standard method. The Rebound tonometer, in particular, has been evaluated for its accuracy and patient tolerance, even in elderly patients and under various conditions. ^{4 6 7 8 9}

Is the treatment Anesthesia-Free Tonometer Tips for Glaucoma a promising treatment?

Yes, Anesthesia-Free Tonometer Tips for Glaucoma is a promising treatment because it allows for measuring eye pressure without the need for anesthesia, making it more comfortable and quicker for patients. It is also accurate and practical for routine use. ^{6 9 10 11 12}

Research Team

Eligibility Criteria

This trial is for individuals with glaucoma. Participants must be willing to have their eye pressure measured using different tonometer tips without anesthesia to find the most comfortable one.

Inclusion Criteria

Presenting for a routine eye exam

Able and willing to give consent

I am 18 years old or older.

Exclusion Criteria

History of alternated corneal sensitivity

I have an active eye infection.

I have had scarring on my cornea.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants compare the tolerability and comfort of 3 different prototype anesthesia-free tonometer tips with the standard tonometer tip

Baseline

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Anesthesia-free Tonometer Tip (Procedure)

Trial Overview The study is testing three prototype tonometer tips made of medical grade silicone (two varying in thickness) and a sterile bandage contact lens against the standard tip with anesthesia, aiming to identify the best option for home use.

Participant Groups

Group I: Medical grade acrylic tip coated with medical grade silicone of a thickness > 100 µm Active Control 1 Intervention

Group II: Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm Active Control 1 Intervention

Group III: Medical grade acrylic tip covered by a sterile commercially available bandage contact lens Active Control 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Duke Eye Center Durham, NC

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2495

Patients Recruited

5,912,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rebound tonometer: ideal tonometer for measurement of accurate intraocular pressure. Suman, S., Agrawal, A., Pal, VK., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of intraocular pressure measurement between rebound, non-contact and Goldmann applanation tonometry in treated glaucoma patients. Vincent, SJ., Vincent, RA., Shields, D., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The non-contact tonometer. Its value and limitations. Shields, MB.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of rebound tonometer for measuring intraocular pressure at deviated angle and position. Takenaka, J., Mochizuki, H., Kunihara, E., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new handheld air impulse tonometer. Fisher, JH., Watson, PG., Spaeth, G.[2009]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring intraocular pressure with the Pulsair 3000 and Rebound tonometers in elderly patients without an anesthetic. Kontiola, A., Puska, P.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Study Between the Goldmann Applanation Tonometer and the Non-Contact Air-Puff Tonometer (Huvitz HNT 7000) in Normal Eyes. Stock, RA., Ströher, C., Sampaio, RR., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of the concordance of Icare&#174; PRO-based rebound and Goldmann applanation tonometry in glaucoma patients. Rödter, TH., Knippschild, S., Baulig, C., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of rebound tonometry with Goldmann applanation tonometry and correlation with central corneal thickness. Iliev, ME., Goldblum, D., Katsoulis, K., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of topical anesthesia on tonometric values of intraocular pressure. Baudouin, C., Gastaud, P.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rebound tonometry and applanation tonometry during narcosis investigation of pediatric glaucoma]. Rosentreter, A., Schild, AM., Lappas, A., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a rebound tonometer (Tonovet) in clinically normal cat eyes. Rusanen, E., Florin, M., Hässig, M., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Rebound tonometer: ideal tonometer for measurement of accurate intraocular pressure. [2018]

2. Australia pubmed.ncbi.nlm.nih.gov

Comparison of intraocular pressure measurement between rebound, non-contact and Goldmann applanation tonometry in treated glaucoma patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The non-contact tonometer. Its value and limitations. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of rebound tonometer for measuring intraocular pressure at deviated angle and position. [2019]

5. England pubmed.ncbi.nlm.nih.gov

A new handheld air impulse tonometer. [2009]

6. Germany pubmed.ncbi.nlm.nih.gov

Measuring intraocular pressure with the Pulsair 3000 and Rebound tonometers in elderly patients without an anesthetic. [2019]

7. New Zealand pubmed.ncbi.nlm.nih.gov

A Comparative Study Between the Goldmann Applanation Tonometer and the Non-Contact Air-Puff Tonometer (Huvitz HNT 7000) in Normal Eyes. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis of the concordance of Icare&#174; PRO-based rebound and Goldmann applanation tonometry in glaucoma patients. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Comparison of rebound tonometry with Goldmann applanation tonometry and correlation with central corneal thickness. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Influence of topical anesthesia on tonometric values of intraocular pressure. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

[Rebound tonometry and applanation tonometry during narcosis investigation of pediatric glaucoma]. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Evaluation of a rebound tonometer (Tonovet) in clinically normal cat eyes. [2019]