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

NCT ID: NCT04932213

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-07

Study Completion Date

2021-11-07

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus Type 1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention group 1: This group receives tropicamide 0.5% drops; Intervention group 2: This group receives tropicamide 1% drops.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Tropicamide 0.5%

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

Group Type ACTIVE_COMPARATOR

Tropicamide Ophthalmic

Intervention Type DRUG

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

Tropicamide 1%

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

Group Type ACTIVE_COMPARATOR

Tropicamide Ophthalmic

Intervention Type DRUG

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

Interventions

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Tropicamide Ophthalmic

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

Intervention Type DRUG

Other Intervention Names

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Mydrax (Sina Darou)

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Semnan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Navid Elmi Sadr

Assistant professor of ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Navid Elmi Sadr, MD

Role: PRINCIPAL_INVESTIGATOR

Semnan University of Medical Sciences, Semnan, Iran

Navid Elmi Sadr, MD

Role: STUDY_DIRECTOR

Semnan University of Medical Sciences, Semnan, Iran

Locations

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Kowsar Semnan Research and Medical Training Center

Semnan, , Iran

Site Status

Countries

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Iran

Other Identifiers

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IRCT

Identifier Type: REGISTRY

Identifier Source: secondary_id

IR.SEMUMS.REC.1400.018

Identifier Type: -

Identifier Source: org_study_id