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.
Investigators
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
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