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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Type 1 Diabetes Mellitus
• Intervention / Treatment: Drug: Tropicamide Ophthalmic

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Semnan, Iran, Islamic Republic of, 3514799442
    • Kowsar Semnan Research and Medical Training Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tropicamide 0.5%; This group receives tropicamide 0.5% (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.; Other Names: Mydrax (Sina Darou)
Active Comparator: Tropicamide 1%; 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.; Other Names: Mydrax (Sina Darou)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Semnan University of Medical Sciences
• Investigators: Principal Investigator: Navid Elmi Sadr, MD, Semnan University of Medical Sciences, Semnan, Iran; Study Director: Navid Elmi Sadr, MD, Semnan University of Medical Sciences, Semnan, Iran

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Actual): November 7, 2021
• Study Completion (Actual): November 7, 2021

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 12, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Mydriatics; Tropicamide
• Other Study ID Numbers: IR.SEMUMS.REC.1400.018; IRCT (Registry Identifier: IRCT20200829048553N1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data can be shared without disclosing the identities of the participants.
• IPD Sharing Time Frame: Access period starts one year after the results are published.
• IPD Sharing Access Criteria: 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No