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

Sponsor
Semnan University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT04932213
Collaborator
(none)
98
Enrollment
1
Location
2
Arms
4
Actual Duration (Months)
24.3
Patients Per Site Per Month

Study Details

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
  • 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

Study Type:
Interventional
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.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 :
Jul 7, 2021
Actual Primary Completion Date :
Nov 7, 2021
Actual Study Completion Date :
Nov 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 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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in Intraocular pressure (IOP) [Before intervention, 30 minutes after intervention]

      The intraocular pressure is measured by Goldmann applanation tonometry

    2. Change from baseline in pupillary diameter [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 [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) [Before intervention, 30 minutes after intervention]

      The ACD is measured by Scheimpflug camera (Oculus Pentacam)

    3. Change from baseline in anterior chamber volume (ACV) [Before intervention, 30 minutes after intervention]

      The ACV is measured by Scheimpflug camera (Oculus Pentacam)

    4. Change from baseline in anterior chamber angle (ACA) [Before intervention, 30 minutes after intervention]

      The ACA is measured by Scheimpflug camera (Oculus Pentacam)

    5. Change from baseline in central corneal thickness (CCT) [Before intervention, 30 minutes after intervention]

      The CCT is measured by Scheimpflug camera (Oculus Pentacam)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 Kowsar Semnan Research and Medical Training Center Semnan Iran, Islamic Republic of 3514799442

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Navid Elmi Sadr, Assistant professor of ophthalmology, Semnan University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT04932213
    Other Study ID Numbers:
    • IR.SEMUMS.REC.1400.018
    • IRCT
    First Posted:
    Jun 21, 2021
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Diabetes Mellitus, Type 1
    Tropicamide

    Study Results

    No Results Posted as of Nov 19, 2021