Effect of Tropicamide 0.5% vs Tropicamide 1% on Intraocular Pressure of Diabetic Patients

Study Overview
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Brief Summary
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The aim of this study is to compare the effect of tropicamide 0.5% and tropicamide 1% on intraocular pressure and anterior chamber parameters in patients with Diabetes Mellitus.

Detailed Description
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Patients with diabetes type 1 and type 2 older than 21 years of age, in the specialized clinic of Kowsar Hospital (Semnan University of Medical Sciences) are examined. Eligible individuals enter the study and are randomly assigned to group 1 or group 2. In each group, visual acuity measurement, slit lamp biomicroscopy and fundus examination are performed. Intraocular pressure is measured with Goldmann applanation tonometer. pupil size, refraction and keratometry are measured with two different autorefractokeratometers. keratometry, pupil size and other anterior chamber parameters are also evaluated by Oculus Pentacam imaging. Then, the patients receive tropicamide 0.5% drops in group 1 and tropicamide 1% drops in group 2. 30 minutes later, all previous measurements are repeated. Patients and the ophthalmologist and the data analyzer are unaware of the drug type.

Official Title
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Comparison of the Effect of Tropicamide 0.5% and Tropicamide 1% on Intraocular Pressure, Pupil Size, Keratometry and Anterior Chamber Parameters in Patients With Type 1 and Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus

Intervention / Treatment
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* Drug: Tropicamide Ophthalmic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Diabetes Mellitus type 1 and 2 Exclusion Criteria: Proliferative diabetic retinopathy History of cataract surgery severe nuclear and cortical cataract Glaucoma Intraocular pressure (IOP) greater than 21 mmHg Familial history of glaucoma Narrow angle (Van Herick 1, 2) Cup to disc ratio greater than 0.5 Pregnancy Pterygium Corneal ectasia History of keratorefractive surgery Corneal dystrophy Iris disorders Anisocoria Iris neovascularization Use of miotics or mydriatics

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention group 1: This group receives tropicamide 0.5% drops; Intervention group 2: This group receives tropicamide 1% drops.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tropicamide 0.5%<br>This group receives tropicamide 0.5% (one drop every 5 minutes for 2 times) drops. | Drug: Tropicamide Ophthalmic<br>* Tropicamide eye drops are used for dilating pupils (mydriasis) to do comprehensive fundus examination.<br>* Other names: Mydrax (Sina Darou);|
| Active Comparator: Tropicamide 1%<br>This group receives tropicamide 1% (one drop every 5 minutes for 2 times) drops. | Drug: Tropicamide Ophthalmic<br>* Tropicamide eye drops are used for dilating pupils (mydriasis) to do comprehensive fundus examination.<br>* Other names: Mydrax (Sina Darou);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Intraocular pressure (IOP) | The intraocular pressure is measured by Goldmann applanation tonometry | Before intervention, 30 minutes after intervention | 
| Change from baseline in pupillary diameter | The diameter of the participants' pupil is measured by Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1) | Before intervention, 30 minutes after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Keratometry | The keratometry is obtained by Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1) | Before intervention, 30 minutes after intervention | 
| Change from baseline in anterior chamber depth (ACD) | The ACD is measured by Scheimpflug camera (Oculus Pentacam) | Before intervention, 30 minutes after intervention | 
| Change from baseline in anterior chamber volume (ACV) | The ACV is measured by Scheimpflug camera (Oculus Pentacam) | Before intervention, 30 minutes after intervention | 
| Change from baseline in anterior chamber angle (ACA) | The ACA is measured by Scheimpflug camera (Oculus Pentacam) | Before intervention, 30 minutes after intervention | 
| Change from baseline in central corneal thickness (CCT) | The CCT is measured by Scheimpflug camera (Oculus Pentacam) | Before intervention, 30 minutes after intervention |