Trials Sponsors Conditions Drugs Pricing

Conditions

Type 2 Diabetes Mellitus Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

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 Outcomes (5)

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
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

Study Arms (2)

Tropicamide 0.5%

ACTIVE COMPARATOR

This group receives tropicamide 0.5% (one drop every 5 minutes for 2 times) drops.

Drug: Tropicamide Ophthalmic

Tropicamide 1%

ACTIVE COMPARATOR

This group receives tropicamide 1% (one drop every 5 minutes for 2 times) drops.

Drug: Tropicamide Ophthalmic

Interventions

Tropicamide OphthalmicDrug

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

Also known as: Mydrax (Sina Darou)

Tropicamide 0.5%Tropicamide 1%

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with Diabetes Mellitus type 1 and 2

You may not qualify if:

Sponsors & Collaborators

Semnan University of Medical Sciences
Otherlead

Study Sites (1)

Kowsar Semnan Research and Medical Training Center

Semnan, 3514799442, Iran

Related Publications (1)

Elmi Sadr N, Ghiasian L, Hadi Y, Hariri R. The effect of cycloplegia on corneal power and diameter measured by an auto-kerato-refractometer in presbyopic patients with type 2 diabetes mellitus: a post-hoc analysis of a randomized clinical trial. BMC Ophthalmol. 2026 Sep 18;26(1):588. doi: 10.1186/s12886-026-05351-1.
PMID: 42768324DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

Navid Elmi Sadr, MD
Semnan University of Medical Sciences, Semnan, Iran
PRINCIPAL INVESTIGATOR
Navid Elmi Sadr, MD
Semnan University of Medical Sciences, Semnan, Iran
STUDY DIRECTOR

Enrollment

98 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: 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.
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant professor of ophthalmology

Study Record Dates

First Submitted

June 7, 2021

First Posted

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Tropicamide 0.5%

Tropicamide 1%

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Tropicamide 0.5%

Tropicamide 1%

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations