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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04932213
• Other study ID #: IR.SEMUMS.REC.1400.018
• Secondary ID: IRCT
• Status: Completed
• Phase: Phase 3
• Start date: July 7, 2021
• Est. completion date: November 7, 2021

Study information

• Verified date: November 2021
• Source: Semnan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: November 7, 2021
• Est. primary completion date: November 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Tropicamide Ophthalmic
Tropicamide eye drops are used for dilating pupils (mydriasis) to do comprehensive fundus examination.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Kowsar Semnan Research and Medical Training Center	Semnan

Sponsors (1)

Lead Sponsor	Collaborator
Semnan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Intraocular pressure (IOP)	The intraocular pressure is measured by Goldmann applanation tonometry	Before intervention, 30 minutes after intervention
Primary	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	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
Secondary	Change from baseline in anterior chamber depth (ACD)	The ACD is measured by Scheimpflug camera (Oculus Pentacam)	Before intervention, 30 minutes after intervention
Secondary	Change from baseline in anterior chamber volume (ACV)	The ACV is measured by Scheimpflug camera (Oculus Pentacam)	Before intervention, 30 minutes after intervention
Secondary	Change from baseline in anterior chamber angle (ACA)	The ACA is measured by Scheimpflug camera (Oculus Pentacam)	Before intervention, 30 minutes after intervention
Secondary	Change from baseline in central corneal thickness (CCT)	The CCT is measured by Scheimpflug camera (Oculus Pentacam)	Before intervention, 30 minutes after intervention