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Completed

NCT Number: NCT04932213

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kowsar Semnan Research and Medical Training Center

Semnan, 3514799442, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tropicamide Ophthalmic

Drug

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

Other names: Mydrax (Sina Darou)

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Semnan University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 21, 2021
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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