Glaucoma and Glaucoma suspect MedDRA version: 14.1 Level: LLT Classification code 10006028 Term: Borderline glaucoma (glaucoma suspect) System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: PT Classification code 10018304 Term: Glaucoma System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: The sample group will include glaucoma and glaucoma suspect patients undergoing intravitreal injections for neovascular (wet) AMD at York Hospital. 1. Patients with neovascular (wet) AMD requiring Lucentis injections 2. Glaucoma or Glaucoma suspect 3. Written informed consent 4. Baseline pre injection Intraocular Pressure of less than 30 mmHg Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: 1. Baseline pre-injection IOP of 30 mmHg or higher 2. Unable to give written informed consent 3. Known allergy to sulphur containing drugs or acetazolamide 4. 18 years or younger 5. Marked kidney or liver disease/dysfunction 6. Supra-renal gland failure 7. Hypercholrcmic adcidosis 8. Hepatic cirrhosis 9. Pregnancy and pre-menopausal women 10. Concomitant use of other oral carbonic anhydrase inhibitors apart from acetazolamide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does oral acetazolamide (Diamox) significantly reduce intraocular pressure in patients with glaucoma, who are receiving Lucentis injections for wet Age-related Macular Degeneration.;Secondary Objective: n/a;Primary end point(s): Primary endpoint is change in IOP at TO, T5, T10 and finally T30. A sample size calculation was based on a change of 9mmHg eye pressure in the intervention group versus no change in placebo group. ;Timepoint(s) of evaluation of this end point: TO minutes, T5 minutes, T10 minutes and finally T30 minutes. | — |
Countries
United Kingdom