Clinical trial NCT04932213: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus
Lead sponsor: Semnan University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 98
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group 1: This group receives tropicamide 0.5% drops; Intervention group 2: This group receives tropicamide 1% drops.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in Intraocular pressure (IOP)
timeFrame: Before intervention, 30 minutes after intervention
measure: Change from baseline in pupillary diameter
timeFrame: Before intervention, 30 minutes after intervention
Secondary outcomes:
measure: Change from baseline in Keratometry
timeFrame: Before intervention, 30 minutes after intervention
measure: Change from baseline in anterior chamber depth (ACD)
timeFrame: Before intervention, 30 minutes after intervention
measure: Change from baseline in anterior chamber volume (ACV)
timeFrame: Before intervention, 30 minutes after intervention
measure: Change from baseline in anterior chamber angle (ACA)
timeFrame: Before intervention, 30 minutes after intervention
measure: Change from baseline in central corneal thickness (CCT)
timeFrame: Before intervention, 30 minutes after intervention
Other outcomes:
Locations:
city: Semnan
country: Iran, Islamic Republic of
facility: Kowsar Semnan Research and Medical Training Center
Study officials:
affiliation: Semnan University of Medical Sciences, Semnan, Iran
name: Navid Elmi Sadr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Semnan University of Medical Sciences, Semnan, Iran
name: Navid Elmi Sadr, MD
role: STUDY_DIRECTOR
References: