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

Primary Purpose

Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Tropicamide Ophthalmic
Sponsored by
Semnan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kowsar Semnan Research and Medical Training Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tropicamide 0.5%

Tropicamide 1%

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in Intraocular pressure (IOP)
The intraocular pressure is measured by Goldmann applanation tonometry
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)

Secondary Outcome Measures

Change from baseline in Keratometry
The keratometry is obtained by Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1)
Change from baseline in anterior chamber depth (ACD)
The ACD is measured by Scheimpflug camera (Oculus Pentacam)
Change from baseline in anterior chamber volume (ACV)
The ACV is measured by Scheimpflug camera (Oculus Pentacam)
Change from baseline in anterior chamber angle (ACA)
The ACA is measured by Scheimpflug camera (Oculus Pentacam)
Change from baseline in central corneal thickness (CCT)
The CCT is measured by Scheimpflug camera (Oculus Pentacam)

Full Information

First Posted
June 7, 2021
Last Updated
November 18, 2021
Sponsor
Semnan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04932213
Brief Title
Effect of Tropicamide 0.5% vs Tropicamide 1% on Intraocular Pressure of Diabetic Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
November 7, 2021 (Actual)
Study Completion Date
November 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semnan University of Medical Sciences

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Intervention group 1: This group receives tropicamide 0.5% drops; Intervention group 2: This group receives tropicamide 1% drops.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tropicamide 0.5%
Arm Type
Active Comparator
Arm Description
This group receives tropicamide 0.5% (one drop every 5 minutes for 2 times) drops.
Arm Title
Tropicamide 1%
Arm Type
Active Comparator
Arm Description
This group receives tropicamide 1% (one drop every 5 minutes for 2 times) drops.
Intervention Type
Drug
Intervention Name(s)
Tropicamide Ophthalmic
Other Intervention Name(s)
Mydrax (Sina Darou)
Intervention Description
Tropicamide eye drops are used for dilating pupils (mydriasis) to do comprehensive fundus examination.
Primary Outcome Measure Information:
Title
Change from baseline in Intraocular pressure (IOP)
Description
The intraocular pressure is measured by Goldmann applanation tonometry
Time Frame
Before intervention, 30 minutes after intervention
Title
Change from baseline in pupillary diameter
Description
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
Secondary Outcome Measure Information:
Title
Change from baseline in Keratometry
Description
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
Title
Change from baseline in anterior chamber depth (ACD)
Description
The ACD is measured by Scheimpflug camera (Oculus Pentacam)
Time Frame
Before intervention, 30 minutes after intervention
Title
Change from baseline in anterior chamber volume (ACV)
Description
The ACV is measured by Scheimpflug camera (Oculus Pentacam)
Time Frame
Before intervention, 30 minutes after intervention
Title
Change from baseline in anterior chamber angle (ACA)
Description
The ACA is measured by Scheimpflug camera (Oculus Pentacam)
Time Frame
Before intervention, 30 minutes after intervention
Title
Change from baseline in central corneal thickness (CCT)
Description
The CCT is measured by Scheimpflug camera (Oculus Pentacam)
Time Frame
Before intervention, 30 minutes after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Navid Elmi Sadr, MD
Organizational Affiliation
Semnan University of Medical Sciences, Semnan, Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Navid Elmi Sadr, MD
Organizational Affiliation
Semnan University of Medical Sciences, Semnan, Iran
Official's Role
Study Director
Facility Information:
Facility Name
Kowsar Semnan Research and Medical Training Center
City
Semnan
ZIP/Postal Code
3514799442
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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