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出境医 / 临床实验 / Effect of Tropicamide 0.5% vs Tropicamide 1% on Intraocular Pressure of Diabetic Patients

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

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Type 1 Diabetes Mellitus Drug: Tropicamide Ophthalmic Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention group 1: This group receives tropicamide 0.5% drops; Intervention group 2: This group receives tropicamide 1% drops.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
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
Actual Study Start Date : July 7, 2021
Actual Primary Completion Date : November 7, 2021
Actual Study Completion Date : November 7, 2021
Arms and Interventions
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 Name: 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 Name: Mydrax (Sina Darou)
Outcome Measures
Primary Outcome Measures :
  1. Change from baseline in Intraocular pressure (IOP) [ Time Frame: Before intervention, 30 minutes after intervention ]
    The intraocular pressure is measured by Goldmann applanation tonometry

  2. Change from baseline in pupillary diameter [ Time Frame: Before intervention, 30 minutes after intervention ]
    The diameter of the participants' pupil is measured by Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1)


Secondary Outcome Measures :
  1. Change from baseline in Keratometry [ Time Frame: Before intervention, 30 minutes after intervention ]
    The keratometry is obtained by Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1)

  2. Change from baseline in anterior chamber depth (ACD) [ Time Frame: Before intervention, 30 minutes after intervention ]
    The ACD is measured by Scheimpflug camera (Oculus Pentacam)

  3. Change from baseline in anterior chamber volume (ACV) [ Time Frame: Before intervention, 30 minutes after intervention ]
    The ACV is measured by Scheimpflug camera (Oculus Pentacam)

  4. Change from baseline in anterior chamber angle (ACA) [ Time Frame: Before intervention, 30 minutes after intervention ]
    The ACA is measured by Scheimpflug camera (Oculus Pentacam)

  5. Change from baseline in central corneal thickness (CCT) [ Time Frame: Before intervention, 30 minutes after intervention ]
    The CCT is measured by Scheimpflug camera (Oculus Pentacam)


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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Iran, Islamic Republic of
Kowsar Semnan Research and Medical Training Center
Semnan, Iran, Islamic Republic of, 3514799442
Sponsors and Collaborators
Semnan University of Medical Sciences
Investigators
Layout table for investigator information
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
Tracking Information
First Submitted Date  ICMJE June 7, 2021
First Posted Date  ICMJE June 21, 2021
Last Update Posted Date November 19, 2021
Actual Study Start Date  ICMJE July 7, 2021
Actual Primary Completion Date November 7, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2021)
  • Change from baseline in Intraocular pressure (IOP) [ Time Frame: Before intervention, 30 minutes after intervention ]
    The intraocular pressure is measured by Goldmann applanation tonometry
  • Change from baseline in pupillary diameter [ Time Frame: Before intervention, 30 minutes after intervention ]
    The diameter of the participants' pupil is measured by Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2021)
  • Change from baseline in Keratometry [ Time Frame: Before intervention, 30 minutes after intervention ]
    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) [ Time Frame: Before intervention, 30 minutes after intervention ]
    The ACD is measured by Scheimpflug camera (Oculus Pentacam)
  • Change from baseline in anterior chamber volume (ACV) [ Time Frame: Before intervention, 30 minutes after intervention ]
    The ACV is measured by Scheimpflug camera (Oculus Pentacam)
  • Change from baseline in anterior chamber angle (ACA) [ Time Frame: Before intervention, 30 minutes after intervention ]
    The ACA is measured by Scheimpflug camera (Oculus Pentacam)
  • Change from baseline in central corneal thickness (CCT) [ Time Frame: Before intervention, 30 minutes after intervention ]
    The CCT is measured by Scheimpflug camera (Oculus Pentacam)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Tropicamide 0.5% vs Tropicamide 1% on Intraocular Pressure of Diabetic Patients
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Intervention group 1: This group receives tropicamide 0.5% drops; Intervention group 2: This group receives tropicamide 1% drops.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Type 1 Diabetes Mellitus
Intervention  ICMJE Drug: Tropicamide Ophthalmic
Tropicamide eye drops are used for dilating pupils (mydriasis) to do comprehensive fundus examination.
Other Name: Mydrax (Sina Darou)
Study Arms  ICMJE
  • Active Comparator: Tropicamide 0.5%
    This group receives tropicamide 0.5% (one drop every 5 minutes for 2 times) drops.
    Intervention: Drug: Tropicamide Ophthalmic
  • Active Comparator: Tropicamide 1%
    This group receives tropicamide 1% (one drop every 5 minutes for 2 times) drops.
    Intervention: Drug: Tropicamide Ophthalmic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2021) 		98
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2021) 		210
Actual Study Completion Date  ICMJE November 7, 2021
Actual Primary Completion Date November 7, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04932213
Other Study ID Numbers  ICMJE IR.SEMUMS.REC.1400.018
IRCT ( Registry Identifier: IRCT20200829048553N1 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data can be shared without disclosing the identities of the participants.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party Navid Elmi Sadr, Semnan University of Medical Sciences
Study Sponsor  ICMJE Semnan University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Semnan University of Medical Sciences
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP