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

Semnan University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Treatments: Drug: Tropicamide Ophthalmic

Study type: Interventional

Funder types: Other

Identifiers

NCT04932213

IR.SEMUMS.REC.1400.018

IRCT (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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98 participants in 2 patient groups

Tropicamide 0.5%

Active Comparator group

Description:

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

Treatment:

Drug: Tropicamide Ophthalmic

Tropicamide 1%

Active Comparator group

Description:

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

Treatment:

Drug: Tropicamide Ophthalmic