A Phase 3 interventional study of Tropicamide Ophthalmic in Type 2 Diabetes Mellitus and Type 1 Diabetes Mellitus, sponsored by Semnan University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-11-19.
Sponsored by Semnan University of Medical Sciences · Phase 3, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 98 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Semnan University of Medical Sciences is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group receives tropicamide 0.5% (one drop every 5 minutes for 2 times) drops.
Drug: Tropicamide Ophthalmic
This group receives tropicamide 1% (one drop every 5 minutes for 2 times) drops.
Drug: Tropicamide Ophthalmic
Tropicamide eye drops are used for dilating pupils (mydriasis) to do comprehensive fundus examination.
Also known as: Mydrax (Sina Darou)
Change from baseline in Intraocular pressure (IOP)
The intraocular pressure is measured by Goldmann applanation tonometry
Time frame: 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)
Time frame: Before intervention, 30 minutes after intervention
Change from baseline in Keratometry
The keratometry is obtained by Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1)
Time frame: Before intervention, 30 minutes after intervention
Change from baseline in anterior chamber depth (ACD)
The ACD is measured by Scheimpflug camera (Oculus Pentacam)
Time frame: Before intervention, 30 minutes after intervention
Change from baseline in anterior chamber volume (ACV)
The ACV is measured by Scheimpflug camera (Oculus Pentacam)
Time frame: Before intervention, 30 minutes after intervention
Change from baseline in anterior chamber angle (ACA)
The ACA is measured by Scheimpflug camera (Oculus Pentacam)
Time frame: Before intervention, 30 minutes after intervention
Change from baseline in central corneal thickness (CCT)
The CCT is measured by Scheimpflug camera (Oculus Pentacam)
Time frame: Before intervention, 30 minutes after intervention
Plan to share: Yes — Data can be shared without disclosing the identities of the participants.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Semnan University of Medical Sciences