Diabetes (DM), Pupil Dilation, Retinopathy, Diabetic
Conditions
Keywords
Pupil, Dilatation, Administration, Topical, Anesthetics, Retinopathy, Diabetic
Brief summary
Pupil dilation is required for many eye conditions. Diabetic patients may need more dilating eye drops to have pupil size large enough for eye exams. This study compares 4 methods of eye drops for pupil dilation in diabetic patients scheduled for retinopathy screening. Possible side effects of the eye drops are monitored during the study.
Detailed description
Diabetic patients participating in this study will be randomed to get 1 drop or 3 drops of dilating drug. And one eye of each patient will be randomed to get 1 drop of anesthetics, while the other eye does not. So there are 4 groups of eyes in the study. Group 1 receive 1 drop of dilating drug. Group 2 receive 1 drop of anesthetics + 1 drop of dilating drug. Group 3 receive 3 drops of dilating drug. And group 4 receive 1 drop of anesthetics + 3 drops of dilating drug. Pupil size will be measured before and after the drops.
Interventions
DRUG1 drop of a 0.8% tropicamide + 5% phenylephrine combination
1 drop of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination
DRUG1 drop of 0.5% tetracaine and 1 drop of a 0.8% tropicamide + 5% phenylephrine combination
1 drop of 0.5% tetracaine (anesthetics) and 1 drop of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination
DRUG3 drops of a 0.8% tropicamide + 5% phenylephrine combination
3 drops of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination
DRUG1 drop of 0.5% tetracaine and 3 drops of a 0.8% tropicamide + 5% phenylephrine combination
1 drop of 0.5% tetracaine (anesthetics) and 3 drops of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination
Sponsors
Burapha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diabetic patients who were scheduled for diabetic retinopathy screening at OPD eye * Age 18 years or older
Exclusion criteria
* Conditions potentially affecting pupillary reaction (e.g., history of uveitis, previous intraocular surgery, posterior synechiae) * Known allergies to the study medications * Systolic blood pressure \> 160 mmHg * Diastolic blood pressure \> 100 mmHg * Pulse rate \> 100 beats/min
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pupillary size | 30 minutes | Measurement of pupillary size in millimeters (at baseline, then every 10 minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure | 30 minutes | Measurement of systolic blood pressure (at baseline, then every 10 minutes) |
| Diastolic blood pressure | 30 minutes | Measurement of diastolic blood pressure (at baseline, then every 10 minutes) |
| Pulse rate | 30 minutes | Measurement of pulse rate (at baseline, then every 10 minutes) |
| Ocular discomfort | When all measurements concluded (at minute 30) | Patients report of ocular discomfort during topical administration and the measurement of pupillary size in pain score (0-10) |
Countries
Thailand
Contacts
PRINCIPAL_INVESTIGATORNattawat Asawaworarit, M.D.
Burapha University
Outcome results
None listed