Protocol summary
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Study aim
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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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Design
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Clinical trial with parallel groups, double-blinded, randomized, phase 3 on 210 patients.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: patients with Diabetes Mellitus type 1 and 2, older than 21 years old;
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), iris neovascularization, pregnancy, corneal dystrophy and ectasia, pterygium, keratorefractive surgery, Iris disorders, miotics or mydriatics use
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Intervention groups
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Intervention group 1: This group receives tropicamide 0.5% drops.
Intervention group 2: This group receives tropicamide 1% drops.
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Main outcome variables
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Intraocular pressure (IOP); pupil diameter
General information
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Reason for update
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The study has been completed.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200829048553N1
Registration date:
2021-05-31, 1400/03/10
Registration timing:
prospective
Last update:
2021-11-21, 1400/08/30
Update count:
1
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Registration date
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2021-05-31, 1400/03/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-06-22, 1400/04/01
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Expected recruitment end date
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2021-10-23, 1400/08/01
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Actual recruitment start date
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2021-07-07, 1400/04/16
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Actual recruitment end date
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2021-11-07, 1400/08/16
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Trial completion date
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2021-11-07, 1400/08/16
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Scientific title
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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
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Public title
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Effect of tropicamide 0.5% vs tropicamide 1% on intraocular pressure of diabetic patients
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Purpose
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Treatment
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Inclusion/Exclusion 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
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Age
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From 21 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
210
Actual sample size reached:
98
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block Randomization: In this study, the randomized block method is used to allocate the participants into two groups. Each block will have 4 units (2 units related to intervention group and 2 units related to comparison group). There will be 6 different combinations of intervention and comparison in each block. Using the computer-generated random numbers, one of the combinations is selected. In this way, patients are balanced into two groups of intervention and comparison.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Secondary Ids
1
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Registry name
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www.ClinicalTrials.gov
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Secondary trial Id
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NCT04932213
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Registration date
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2021-06-07, 1400/03/17
Ethics committees
1
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Ethics committee
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Approval date
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2021-04-27, 1400/02/07
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Ethics committee reference number
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IR.SEMUMS.REC.1400.018
Health conditions studied
1
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Description of health condition studied
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Type 2 diabetes mellitus
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ICD-10 code
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E11
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ICD-10 code description
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Type 2 diabetes mellitus
2
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Description of health condition studied
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Type 1 diabetes mellitus
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ICD-10 code
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E10
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ICD-10 code description
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Type 1 diabetes mellitus
Primary outcomes
1
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Description
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Intraocular pressure (IOP)
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Timepoint
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Before intervention, 30 minutes after intervention
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Method of measurement
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Goldmann applanation tonometry
2
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Description
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Pupillary diameter
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Timepoint
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Before intervention, 30 minutes after intervention
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Method of measurement
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Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1);
Secondary outcomes
1
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Description
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Keratometry
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Timepoint
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Before intervention, 30 minutes after intervention
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Method of measurement
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Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1);
2
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Description
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Anterior chamber parameters
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Timepoint
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Before intervention, 30 minutes after intervention
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Method of measurement
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Scheimpflug camera (Oculus Pentacam)
Intervention groups
1
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Description
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Intervention group: this group receives tropicamide 0.5% (one drop every 5 minutes for 2 times) drops.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: this group receives tropicamide 1% (one drop every 5 minutes for 2 times) drops.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Semnan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Data can be shared without disclosing the identities of the participants
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When the data will become available and for how long
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Access period starts one year after the results are published
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Researchers can use the data for systematic review studies and meta-analysis.
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From where data/document is obtainable
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Contact the person in charge of the scientific inquiries of the project by e-mail
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What processes are involved for a request to access data/document
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After receiving the request e-mail, if the person is eligible, the data will be sent
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Comments
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