Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Conditions
Brief summary
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
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.
Interventions
DRUGTropicamide Ophthalmic
Tropicamide eye drops are used for dilating pupils (mydriasis) to do comprehensive fundus examination.
Sponsors
Semnan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Intervention group 1: This group receives tropicamide 0.5% drops; Intervention group 2: This group receives tropicamide 1% drops.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Intraocular pressure (IOP) | Before intervention, 30 minutes after intervention | The intraocular pressure is measured by Goldmann applanation tonometry |
| Change from baseline in pupillary diameter | Before intervention, 30 minutes after intervention | The diameter of the participants' pupil is measured by Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in anterior chamber volume (ACV) | Before intervention, 30 minutes after intervention | The ACV is measured by Scheimpflug camera (Oculus Pentacam) |
| Change from baseline in Keratometry | Before intervention, 30 minutes after intervention | The keratometry is obtained by Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1) |
| Change from baseline in central corneal thickness (CCT) | Before intervention, 30 minutes after intervention | The CCT is measured by Scheimpflug camera (Oculus Pentacam) |
| Change from baseline in anterior chamber angle (ACA) | Before intervention, 30 minutes after intervention | The ACA is measured by Scheimpflug camera (Oculus Pentacam) |
| Change from baseline in anterior chamber depth (ACD) | Before intervention, 30 minutes after intervention | The ACD is measured by Scheimpflug camera (Oculus Pentacam) |
Countries
Iran
Outcome results
None listed