RecruitingPhase 1ACTRN12611001225909

The effect of topical glucose on vitreous glucose concentration

The effect of topical glucose on vitreous glucose concentration in 20 non-diabetic subjects.

Sponsor

Robert Casson

Enrollment

20 participants

Start Date

Dec 6, 2010

Study Type

Interventional

Conditions

Vitreous glucose concentration of the Eye

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This pilot study is exploring whether putting glucose (sugar) drops in the eye can temporarily raise the level of glucose inside the eye (in the vitreous — the jelly-like fluid at the back of the eye). Researchers want to know if this works before testing glucose eye drops as a potential treatment to help protect nerves in patients with glaucoma. This study is specifically for people who are already scheduled to have a vitrectomy (a standard eye operation) for other clinical reasons. You may be eligible if: - You are 18 years or older - You are already scheduled to have a vitrectomy at the Royal Adelaide Hospital for a clinically indicated reason - You do not have diabetes You may NOT be eligible if: - You have diabetes (any type) - You have a vitreous haemorrhage (bleeding inside the eye) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.

Locations(1)

Australia

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ACTRN12611001225909