Skip to main content
Clinical Trials/ISRCTN22626706
ISRCTN22626706
Active, not recruiting
未知

A feasibility study: The efficacy and safety of heat applied to closed eyelids in enhancing the delivery of ocular hypotensive eye drops in the treatment of primary open-angle glaucoma

orth West Anglia NHS Foundation Trust0 sites24 target enrollmentSeptember 27, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Glaucoma
Sponsor
orth West Anglia NHS Foundation Trust
Enrollment
24
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 27, 2023
End Date
December 1, 2024
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
orth West Anglia NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

  • 1\. Informed consent signed and dated
  • 2\. Patients diagnosed with bilateral primary open\-angle glaucoma (POAG) or ocular hypertension (OHT)
  • 3\. Patient aged \=18 years old
  • 4\. Both eyes with a central corneal thickness of between 500\-600 µm
  • 5\. Both eyes with a diagnosis of POAG or OHT, initially treated and controlled for at least six months by a prostaglandin analogue monotherapy (mane instillation)
  • 6\. IOP \= 24 mmHg in at least one eye POAG
  • 7\. IOP \= 30 mmHg in at least one eye OHT

Exclusion Criteria

  • 1\. Fundus examination not performed or not available within 12 months
  • 2\. Visual field not performed or not available within 12 months
  • 3\. Advanced stage of glaucoma, defined by at least one of the following criteria:
  • 4\. Absolute defect in the ten degrees central point of the visual fields
  • 5\. Severe visual field loss: MD \< \-18 dB
  • 6\. Risk of visual field worsening as a consequence of participation in the study according to the investigator’s best judgment
  • 7\. Far best corrected visual acuity \= \+0\.7 logMAR
  • 8\. History of trauma, infection, clinically significant inflammation within the previous three months
  • 9\. Ongoing or known history of ocular allergy and/or uveitis and/or viral infection
  • 10\. Clinically significant or progressive retinal disease (e.g. retinal degeneration, diabetic retinopathy, retinal detachment)

Outcomes

Primary Outcomes

Not specified

Similar Trials