Determining the efficacy of 1% pilocarpine eye drops in the relative improvement of symptoms in Patients with presbyopia.
Design
A community-based, practice-oriented, parallel-group, triple-blind, randomized controlled clinical trial
Settings and conduct
This study will be conducted on 60 patients referred to Shahid Sadoughi Hospital in Yazd diagnosed with presbyopia. The uncorrected near visual acuity and uncorrected distance visual acuity of the patients is checked and recorded with the Snellen chart, then the patients are divided into two groups A and B using a random table of numbers from 1 to 60, and each number is randomly assigned to one group (A or B ) . For each patient, the corresponding drop is prescribed. After starting the treatment, his visual acuity will be re-measured based on the times mentioned in the goals. (In order for the study to be a three-blind study, pilocarpine 1% drops and Tearlose drops are prepared by the pharmacist of the Shahid Sadoughi Hospital pharmacy in the same package labeled A or B, and only the pharmacist knows the type of drops. (The researcher, the patient and the statistical consultant are not informed).
Participants/Inclusion and exclusion criteria
Patients 40-60 years old with presbyopia who consent to participate in the study.
Exit criteria:
Presence of other simultaneous eye diseases (Amblyopia - Corneal opacity - Cataract - Glaucoma - High myopia - Retinal disorders - Eye surgeries and eye trauma)
Severe sensitivity and side effects to eye drops
Taking drugs that interact with pilocarpine (including amitriptyline, nortriptyline, doxepin and other drugs that affect the brain and nervous system)
Intervention groups
1) The intervention group treated with 1% pilocarpine eye drops
2) control group treated with artificial tear eye drops (tearlose)
Main outcome variables
uncorrected visual acuity (near and distance)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240325061363N1
Registration date:2024-04-20, 1403/02/01
Registration timing:registered_while_recruiting
Last update:2024-04-20, 1403/02/01
Update count:0
Registration date
2024-04-20, 1403/02/01
Registrant information
Name
Mohammad hossein Abutorabi zarchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 0782
Email address
m.h.abootorabi222@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-06, 1403/01/18
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of pilocarpine 1% eye drop on the relative improvement of presbyopia
Public title
the effect of pilocarpine 1% eye drop on the relative improvement of presbyopia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 40-60 years
Suffering from presbyopia
Uncorrected near visual acuity: 20/40 to 20/100
Exclusion criteria:
Eye diseases (including glaucoma, cataracts, amblyopia, high myopia, eye trauma, congenital pupil abnormalities, corneal opacity, intraocular surgeries)
Severe sensitivity and side effects to eye drops
Taking drugs that interact with pilocarpine
Age
From 40 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups A and B using a random table of numbers from 1 to 60 and each number will be randomly assigned to a group (A or B) and the corresponding drops will be prescribed for each group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order for the study to be three-way blind, pilocarpine 1% drops and Tearlose artificial tears drops are prepared by the pharmacist of Shahid Sadouqi Hospital pharmacy (Mr. Dr. Fallah) in the same packaging with A or B stickers, and only he knows The type of drops A and B (researcher, patient and statistical consultant are not informed) and after collecting and announcing the results, the type of drops will be determined (announced) and the general statistical results will be reported based on the type of drops used by the patients.
Placebo
Used
Assignment
Parallel
Other design features
After the patient consumes the drops, his uncorrected near visual acuity and uncorrected far visual acuity are measured again based on the times mentioned in the goals, and on the 30th day after examination with a slit lamp, the side effects of the drug are also measured.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of school of medicine- Shahid Sadoughi University of Medical Sciences
Street address
Vice President of Research and Technology of yazd Shahid Sadougi University of Medical Sciences, Imam Reza Research Educational Complex, Student Blvd., Imam Hossein Square, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۱۸۸۶۳۷
Approval date
2024-03-13, 1402/12/23
Ethics committee reference number
IR.SSU.MEDICINE.REC.1402.405
Health conditions studied
1
Description of health condition studied
presbyopia
ICD-10 code
H52.4
ICD-10 code description
Presbyopia
Primary outcomes
1
Description
Uncorrected near visual acuity and uncorrected distance visual acuity
Timepoint
Before the intervention, 20 minutes later, one hour and six hours later, as well as on the 14th and 30th days
Method of measurement
Snellen chart
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: sterile eye drops Pilocarpine 1% (Sina darou company) every morning, one drop in each eye for one month
Category
Treatment - Drugs
2
Description
Control group: sterile eye drops Tearlose (Sina darou company) every morning, one drop in each eye for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yard Shahid Sadoughi Hospital
Full name of responsible person
Mohammad hosein Abutorabi zarchi
Street address
Shahid sadoughi Hospital, Ibn Sina Street, Shahid Ghandi Boulevard, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3822 4000
Email
international@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Masoud Mirzaei
Street address
Vice President of Research and Technology of Yazd Shahid Sadoughi University of Medical Sciences, Imam Reza Research Educational Complex, Student Blvd., Imam Hossein Square, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۱۸۸۶۳۷
Phone
+98 35 3628 8114
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Mohammad hosein Abutorabi zarchi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
No. 11, South Rezvan Alley 2, Professor Hasabi Blvd., University Town
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۱۱۶۷۸۸
Phone
+98 35 3820 0782
Email
m.h.abootorabi222@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad hosein Abutorabi zarchi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
No. 11, South Rezvan Alley 2, Professor Hasabi Blvd., University Town
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۱۱۶۷۸۸
Phone
+98 35 3820 0782
Email
m.h.abootorabi222@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad hosein Abutorabi zarchi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
No. 11, South Rezvan Alley 2, Professor Hasabi Blvd., University Town
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۱۱۶۷۸۸
Phone
+98 35 3820 0782
Email
m.h.abootorabi222@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
Clinical study report
When the data will become available and for how long
After completing the study and printing the results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
As a review of texts in other articles
From where data/document is obtainable
responsible author
What processes are involved for a request to access data/document