None listed
Conditions
Brief summary
To determine whether a brief period of topical glucose application to the eye can transiently elevate the vitreous glucose concentration. This is a pilot study designed to provide motivation (or not) to proceed to further research. It would be inappropriate to proceed without a pilot study of this nature We aim to proceed to a human trial using topical glucose as a neurorecovery agent in glaucoma patients. However, before proceeding to this trial we need to establish that topical glucose can elevate the vitreous glucose concentration. This is a Phase I type study in the sense that glucose eye drops have not been previously used therapeutically and we are not assessing efficacy. But it differs from a classic Phase I study in the sense that we are not seeking to assess the dose at which the glucose becomes unacceptably toxic; however, we believe that a modified dose escalation strategy would provide the optimal safety and still provide the necessary vitreous concentration data for statistical analysis.
Interventions
Treatment: The pre-operative eye will receive a drop of sterile glucose (10microlitres), every 5 minutes for one hour prior to planned elective vitrectomy.
6 patients will receive saline eye drops and serve as controls.
The next 2 patients will receive 10% glucose drops.
If no adverse effects are observed then the next 6 patients will receive 25%
glucose.
If > 2 patient develop more than mild toxicity then we will revert back to 10 %
glucose.
If = 2 patient develop toxicity at this dose the ne
Treatment: The pre-operative eye will receive a drop of sterile glucose (10microlitres), every 5 minutes for one hour prior to planned elective vitrectomy. 6 patients will receive saline eye drops and serve as controls. The next 2 patients will receive 10% glucose drops. If no adverse effects are observed then the next 6 patients will receive 25% glucose. If > 2 patient develop more than mild toxicity then we will revert back to 10 % glucose. If = 2 patient develop toxicity at this dose the next 6 patients will receive 50% glucose. If > 2 patients develop more than mild toxicity we will revert back to 25% glucose. If patients develop toxicity at 10% glucose, the study will be ceased. Outcome: Intraoperatively, as part of the routine vitrectomy, a 100 micolitre sample of vitreous will be collected within 30 minutes of the last drop instilled. This has no effect on the outcome of the procedure. The sample will be sent for glucose concentration analysis.
Sponsors
Robert Casson
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects: 20 non-diabetic will be recruited from the the vitreoretinal service at the RAH Inclusion Criteria: Patients will have been booked to undergo elective vitrectomy i.e these patients will already be undergoing a clinically-indicated vitrectomy
Exclusion criteria
History of diabetes mellitus Vitreous haemorrhage
Outcome results
None listed