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
Overview
- Phase
- Phase 3
- Intervention
- Tropicamide Ophthalmic
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Semnan University of Medical Sciences
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Change from baseline in Intraocular pressure (IOP)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Navid Elmi Sadr
Assistant professor of ophthalmology
Semnan University of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •Patients with Diabetes Mellitus type 1 and 2
Exclusion Criteria
- •Proliferative diabetic retinopathy
- •History of cataract surgery
- •severe nuclear and cortical cataract
- •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
Arms & Interventions
Tropicamide 0.5%
This group receives tropicamide 0.5% (one drop every 5 minutes for 2 times) drops.
Intervention: Tropicamide Ophthalmic
Tropicamide 1%
This group receives tropicamide 1% (one drop every 5 minutes for 2 times) drops.
Intervention: Tropicamide Ophthalmic
Outcomes
Primary Outcomes
Change from baseline in Intraocular pressure (IOP)
Time Frame: Before intervention, 30 minutes after intervention
The intraocular pressure is measured by Goldmann applanation tonometry
Change from baseline in pupillary diameter
Time Frame: 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 Outcomes
- Change from baseline in anterior chamber angle (ACA)(Before intervention, 30 minutes after intervention)
- Change from baseline in central corneal thickness (CCT)(Before intervention, 30 minutes after intervention)
- Change from baseline in Keratometry(Before intervention, 30 minutes after intervention)
- Change from baseline in anterior chamber depth (ACD)(Before intervention, 30 minutes after intervention)
- Change from baseline in anterior chamber volume (ACV)(Before intervention, 30 minutes after intervention)