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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 drop | Experimental | 1 drop of a 0.8% tropicamide - 5% phenylephrine combination |
|
| 2 drops | Experimental | 1 drop of tetracaine and 1 drop of a 0.8% tropicamide - 5% phenylephrine combination |
|
| 3 drops | Experimental | 3 drops of a 0.8% tropicamide - 5% phenylephrine combination |
|
| 4 drops | Experimental | 1 drop of tetracaine and 3 drops of a 0.8% tropicamide - 5% phenylephrine combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 drop of a 0.8% tropicamide + 5% phenylephrine combination | Drug | 1 drop of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pupillary size | Measurement of pupillary size in millimeters (at baseline, then every 10 minutes) | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure | Measurement of systolic blood pressure (at baseline, then every 10 minutes) | 30 minutes |
| Diastolic blood pressure | Measurement of diastolic blood pressure (at baseline, then every 10 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nattawat Asawaworarit, M.D. | Burapha University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burapha University | Chon Buri | 20131 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22303506 | Background | Bhatia J, Varghese M, Bhatia A. Effect of 10% phenylephrine eye drops on systemic blood pressure in normotensive & hypertensive patient. Oman Med J. 2009 Jan;24(1):30-2. doi: 10.5001/omj.2009.8. | |
| 12642324 | Background | Kenawy NB, Jabir M. Phenylephrine 2.5% and 10% in phacoemulsification under topical anaesthesia: is there an effect on systemic blood pressure? Br J Ophthalmol. 2003 Apr;87(4):505-6. doi: 10.1136/bjo.87.4.505. No abstract available. |
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IPD used in the results publication
IPD and supporting information will be available one year after publicaiton and for two years period.
Direct contact to the corresponding author
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| 1 drop of 0.5% tetracaine and 1 drop of a 0.8% tropicamide + 5% phenylephrine combination | Drug | 1 drop of 0.5% tetracaine (anesthetics) and 1 drop of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination |
|
| 3 drops of a 0.8% tropicamide + 5% phenylephrine combination | Drug | 3 drops of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination |
|
| 1 drop of 0.5% tetracaine and 3 drops of a 0.8% tropicamide + 5% phenylephrine combination | Drug | 1 drop of 0.5% tetracaine (anesthetics) and 3 drops of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination |
|
| 30 minutes |
| Pulse rate | Measurement of pulse rate (at baseline, then every 10 minutes) | 30 minutes |
| Ocular discomfort | Patients report of ocular discomfort during topical administration and the measurement of pupillary size in pain score (0-10) | When all measurements concluded (at minute 30) |
| 8090095 | Background | Chin KW, Law NM, Chin MK. Phenylephrine eye drops in ophthalmic surgery--a clinical study on cardiovascular effects. Med J Malaysia. 1994 Jun;49(2):158-63. |
| 7362505 | Background | Brown MM, Brown GC, Spaeth GL. Lack of side effects from topically administered 10% phenylephrine eyedrops. A controlled study. Arch Ophthalmol. 1980 Mar;98(3):487-9. doi: 10.1001/archopht.1980.01020030483009. |
| 655237 | Background | Leopold IH. The phenylephrine saga--a drug dilemma. Am J Ophthalmol. 1978 Apr;85(4):572-4. doi: 10.1016/s0002-9394(14)75261-4. No abstract available. |
| 19478547 | Background | Motta MM, Coblentz J, Fernandes BF, Burnier MN Jr. Mydriatic and cardiovascular effects of phenylephrine 2.5% versus phenylephrine 10%, both associated with tropicamide 1%. Ophthalmic Res. 2009;42(2):87-9. doi: 10.1159/000220601. Epub 2009 May 27. |
| 33727791 | Background | Shrivastava AK, Nayak S, Anto M. Efficacy of Nepafenac versus Flurbiprofen in Maintaining Intraoperative Mydriasis During Phacoemulsification: A Comparative Study. Clin Ophthalmol. 2021 Mar 9;15:1085-1093. doi: 10.2147/OPTH.S303480. eCollection 2021. |
| 2625616 | Background | Kergoat H, Lovasik JV, Doughty MJ. A pupillographic evaluation of a phenylephrine HCl 5%-tropicamide 0.8% combination mydriatic. J Ocul Pharmacol. 1989 Fall;5(3):199-216. doi: 10.1089/jop.1989.5.199. |
| 19700872 | Background | Trinavarat A, Pituksung A. Effective pupil dilatation with a mixture of 0.75% tropicamide and 2.5% phenylephrine: A randomized controlled trial. Indian J Ophthalmol. 2009 Sep-Oct;57(5):351-4. doi: 10.4103/0301-4738.55070. |
| 7258285 | Background | Pollack SL, Hunt JS, Polse KA. Dose-response effects of tropicamide HCl. Am J Optom Physiol Opt. 1981 May;58(5):361-6. doi: 10.1097/00006324-198105000-00003. |
| 7425917 | Background | Sinclair SH, Pelham V, Giovanoni R, Regan CD. Mydriatic solution for outpatient indirect ophthalmoscopy. Arch Ophthalmol. 1980 Sep;98(9):1572-4. doi: 10.1001/archopht.1980.01020040424004. |
| 27321772 | Background | Bhurayanontachai P, Saengkaew S, Apiromruck P. Efficacy of an eye drop mixture for pupillary dilatation: A randomized comparative study. J Optom. 2017 Apr-Jun;10(2):111-116. doi: 10.1016/j.optom.2016.04.007. Epub 2016 Jun 16. |
| 19337478 | Background | Park JH, Lee YC, Lee SY. The comparison of mydriatic effect between two drugs of different mechanism. Korean J Ophthalmol. 2009 Mar;23(1):40-2. doi: 10.3341/kjo.2009.23.1.40. Epub 2009 Mar 9. |
| 11381064 | Background | Ghose S, Garodia VK, Sachdev MS, Kumar H, Biswas NR, Pandey RM. Evaluation of potentiating effect of a drop of lignocaine on tropicamide-induced mydriasis. Invest Ophthalmol Vis Sci. 2001 Jun;42(7):1581-5. |
| 7369319 | Background | Apt L, Henrick A. Pupillary dilatation with single eyedrop mydriatic combinations. Am J Ophthalmol. 1980 Apr;89(4):553-9. doi: 10.1016/0002-9394(80)90065-3. |
| 16170985 | Background | Datta S, Biswas NR, Saxena R, Deepak KK, Menon V, Garg SP, Tandon R. Ocular and cardiovascular autonomic function in diabetic patients with varying severity of retinopathy. Indian J Physiol Pharmacol. 2005 Apr;49(2):171-8. |
| 3044851 | Background | Clark CV. Ocular autonomic nerve function in proliferative diabetic retinopathy. Eye (Lond). 1988;2 ( Pt 1):96-101. doi: 10.1038/eye.1988.20. |
| 19958108 | Background | Coblentz J, Motta MM, Fernandes BF, Burnier MN Jr, Vianna RN. Comparison between obtained mydriasis in type 2 diabetics and non-diabetic patients. Curr Eye Res. 2009 Nov;34(11):925-7. doi: 10.3109/02713680903205220. |
| 21879887 | Background | Lei HL, Yang KJ, Sun CC, Chen CH, Huang BY, Ng SC, Yeung L. Obtained mydriasis in long-term type 2 diabetic patients. J Ocul Pharmacol Ther. 2011 Dec;27(6):599-602. doi: 10.1089/jop.2011.0090. Epub 2011 Aug 31. |
| 2729817 | Background | Alio J, Hernandez I, Millan A, Sanchez J. Pupil responsiveness in diabetes mellitus. Ann Ophthalmol. 1989 Apr;21(4):132-7. |
| 17081420 | Background | Yang YB, Yu YB, Fu Q. [The autonomic pupillary dysfunction in type II diabetes mellitus]. Zhonghua Yan Ke Za Zhi. 2006 Jul;42(7):616-9. Chinese. |
| 8462391 | Background | Schwingshandl J, Simpson JM, Donaghue K, Bonney MA, Howard NJ, Silink M. Pupillary abnormalities in type I diabetes occurring during adolescence. Comparisons with cardiovascular reflexes. Diabetes Care. 1993 Apr;16(4):630-3. doi: 10.2337/diacare.16.4.630. |
| 6759259 | Background | Hreidarsson AB. Pupil size in insulin-dependent diabetes. Relationship to duration, metabolic control, and long-term manifestations. Diabetes. 1982 May;31(5 Pt 1):442-8. doi: 10.2337/diab.31.5.442. |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003930 | Diabetic Retinopathy |
| D015878 | Mydriasis |
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D011681 | Pupil Disorders |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014331 | Tropicamide |
| D013748 | Tetracaine |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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