NCT04932213

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at below P25 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2021

Shorter than P25 for phase_3 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

July 7, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2021

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

June 7, 2021

Last Update Submit

November 18, 2021

Conditions

Type 2 Diabetes MellitusType 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:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kowsar Semnan Research and Medical Training Center

Semnan, 3514799442, Iran

Location

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

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
Model Details: Intervention group 1: This group receives tropicamide 0.5% drops; Intervention group 2: This group receives tropicamide 1% drops.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of ophthalmology

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 21, 2021

Study Start

July 7, 2021

Primary Completion

November 7, 2021

Study Completion

November 7, 2021

Last Updated

November 19, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

Data can be shared without disclosing the identities of the participants.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Access period starts one year after the results are published.
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

Locations

IR(1)