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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General information
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2021-07-07, 1400/04/16
2021-07-07 00:00:00
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2021-11-07, 1400/08/16
2021-11-07 00:00:00
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2021-11-07, 1400/08/16
2021-11-07 00:00:00
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The study has been completed.
The study has been completed.
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مطالعه خاتمه یافته است.
مطالعه خاتمه یافته است.
Secondary Ids
#1
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www.ClinicalTrials.gov
www.ClinicalTrials.gov
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NCT04932213
NCT04932213
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2021-06-07, 1400/03/17
2021-06-07 00:00:00
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Parviz kokhaei
Full name of responsible person - Persian: پرویز کوخایی
Street address - English: Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran
Street address - Persian: سمنان، بلوار بسیج، ستاد مرکزی دانشگاه علوم پزشکی استان سمنان، معاونت تحقیقات و فناوری
City - English: semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3514799442
Phone: +98 23 3345 1336
Fax:
Email: rds@semums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Parviz kokhaei
Full name of responsible person - Persian: پرویز کوخایی
Street address - English: Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran
Street address - Persian: سمنان، بلوار بسیج، ستاد مرکزی دانشگاه علوم پزشکی استان سمنان، معاونت تحقیقات و فناوری
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3514799442
Phone: +98 23 3345 1336
Fax:
Email: rds@semums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Parviz kokhaei Full name of responsible person - Persian: پرویز کوخایی Street address - English: Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran Street address - Persian: سمنان، بلوار بسیج، ستاد مرکزی دانشگاه علوم پزشکی استان سمنان، معاونت تحقیقات و فناوری City - English: semnanSemnan City - Persian: سمنان Province: Semnan Country: Iran (Islamic Republic of) Postal code: 3514799442 Phone: +98 23 3345 1336 Fax: Email: rds@semums.ac.ir Web page address:
Protocol summary
Study aim
To compare the effect of tropicamide 0.5% and tropicamide 1% on intraocular pressure and anterior chamber parameters in patients with Diabetes Mellitus
Design
Clinical trial with parallel groups, double-blinded, randomized, phase 3 on 210 patients.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
Intervention group 1: This group receives tropicamide 0.5% drops.
Intervention group 2: This group receives tropicamide 1% drops.
Main outcome variables
Intraocular pressure (IOP); pupil diameter
General information
Reason for update
The study has been completed.
Acronym
IRCT registration information
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
Registration date
2021-05-31, 1400/03/10
Registrant information
Name
Navid Elmi Sadr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4422 2462
Email address
elmisadr.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
2021-07-07, 1400/04/16
Actual recruitment end date
2021-11-07, 1400/08/16
Trial completion date
2021-11-07, 1400/08/16
Scientific 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
Public title
Effect of tropicamide 0.5% vs tropicamide 1% on intraocular pressure of diabetic patients
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 21 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
210
Actual sample size reached:
98
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
www.ClinicalTrials.gov
Secondary trial Id
NCT04932213
Registration date
2021-06-07, 1400/03/17
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of semnan university of medical sciences
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran
City
semnan
Province
Semnan
Postal code
3514799442
Approval date
2021-04-27, 1400/02/07
Ethics committee reference number
IR.SEMUMS.REC.1400.018
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
2
Description of health condition studied
Type 1 diabetes mellitus
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Intraocular pressure (IOP)
Timepoint
Before intervention, 30 minutes after intervention
Method of measurement
Goldmann applanation tonometry
2
Description
Pupillary diameter
Timepoint
Before intervention, 30 minutes after intervention
Method of measurement
Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1);
Secondary outcomes
1
Description
Keratometry
Timepoint
Before intervention, 30 minutes after intervention
Method of measurement
Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1);
2
Description
Anterior chamber parameters
Timepoint
Before intervention, 30 minutes after intervention
Method of measurement
Scheimpflug camera (Oculus Pentacam)
Intervention groups
1
Description
Intervention group: this group receives tropicamide 0.5% (one drop every 5 minutes for 2 times) drops.
Category
Treatment - Drugs
2
Description
Intervention group: this group receives tropicamide 1% (one drop every 5 minutes for 2 times) drops.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Semnan Research and Medical Training Center
Full name of responsible person
Navid Elmi Sadr
Street address
Kowsar Semnan Research and Medical Training Center, semnan, iran
City
semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3343 7824
Email
kosarhos@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz kokhaei
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
rds@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Navis Elmi Sadr
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Kowsar Semnan Research and Medical Training Center, semnan, iran
City
semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3343 7824
Email
navid.elmi.sadr@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Navid Elmi Sadr
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Kowsar Semnan Research and Medical Training Center, semnan, iran
City
semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3343 7824
Email
navid.elmi.sadr@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Navid Elmi Sadr
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Kowsar Semnan Research and Medical Training Center, semnan, iran
City
semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3343 7824
Email
navid.elmi.sadr@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data can be shared without disclosing the identities of the participants
When the data will become available and for how long
Access period starts one year after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers can use the data for systematic review studies and meta-analysis.
From where data/document is obtainable
Contact the person in charge of the scientific inquiries of the project by e-mail
What processes are involved for a request to access data/document
After receiving the request e-mail, if the person is eligible, the data will be sent