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| ID | Type | Description | Link |
|---|---|---|---|
| IRCT | Registry Identifier | IRCT20200829048553N1 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tropicamide 0.5% | Active Comparator | This group receives tropicamide 0.5% (one drop every 5 minutes for 2 times) drops. |
|
| Tropicamide 1% | Active Comparator | This group receives tropicamide 1% (one drop every 5 minutes for 2 times) drops. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tropicamide Ophthalmic | Drug | Tropicamide eye drops are used for dilating pupils (mydriasis) to do comprehensive fundus examination. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Navid Elmi Sadr, MD | Semnan University of Medical Sciences, Semnan, Iran | Principal Investigator |
| Navid Elmi Sadr, MD | Semnan University of Medical Sciences, Semnan, Iran | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kowsar Semnan Research and Medical Training Center | Semnan | 3514799442 | Iran |
Data can be shared without disclosing the identities of the participants.
Access period starts one year after the results are published.
Researchers can use the data for systematic review studies and meta-analysis. Researchers working in academic and scientific institutions can contact the person in charge of the scientific inquiries of the project by e-mail. After receiving the request e-mail, if the person is eligible, the data will be sent
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Intervention group 1: This group receives tropicamide 0.5% drops; Intervention group 2: This group receives tropicamide 1% drops.
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The drops are instilled into the patients' eye by a nurse. Study participants are unaware of the type of medication used. The outcome assessor (ophthalmologist) does not know the type of medication used for each patient. The data is analyzed by an biostatistician. He or she also does not know the type of drug used for each patient.
|
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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |