Determining the effect of vision therapy on delaying or reducing the symptoms of presbyopia
Design
A controlled, parallel-group, single-blind, non-randomized clinical trial on 72 primary presbyopic patients.
Settings and conduct
At the optometry office in Qazvin, Participants are randomly assigned to two groups exercise and glasses (36 each). Without the examiner's knowledge, one group is given accommodative exercise and the other group glasses. Therapy sessions will include exercises to improve amplitude and facility of accommodation. Exercises will be given for 15 minutes a day, 5 days a week, for 8 weeks.
Exercises include: 1; HART CHART DISTANCE-TO-NEAR ACCOMMODATIVE ROCK (binocular).
Exercise 2; Push-ups and push-downs.
Exercise 3; Includes: Loose lens rock (binocular).
Participants/Inclusion and exclusion criteria
Ages 40 to 45 years old
Inclusion criteria:
1-Age 40-45 years.
2-Good general condition.
3- Absence of chronic diseases affecting accommodation.
4- Absence of medication affecting accommodation and near vision on a continuous basis.
5- Absence of chronic eye diseases.
6- Minimum uncorrected near vision of20/40.
Exclusion criteria:
1- Inability of the individual to perform the tests
2- Reluctance of the individual to continue the test
3- Strabismus, moderate and severe amblyopia, significant eye disease, previous surgery or drug treatments for presbyopia.
Because refractive errors are corrected for testing and exercises, the type of refractive error was excluded from the inclusion and exclusion criteria.
Intervention groups
Participants will be assigned to two groups exercise and glasses. The exercise group will be given vision therapy exercises, and the glasses group will be given glasses for near work.
Main outcome variables
Accommodative amplitude and Accommodative facility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251018067676N1
Registration date:2025-11-01, 1404/08/10
Registration timing:prospective
Last update:2025-11-01, 1404/08/10
Update count:0
Registration date
2025-11-01, 1404/08/10
Registrant information
Name
azam abdollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3334 1721
Email address
azaabd98@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-11-19, 1404/08/28
Expected recruitment end date
2026-11-19, 1405/08/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vision therapy on reduction or delaying presbyopia symptoms
Public title
Evaluation the effect of vision therapy on presbyopia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40-45 years.
Good general condition.
No chronic diseases affecting accommodation.
No use of drugs affecting accommodation and near vision on a continuous basis.
No chronic eye diseases.
Minimum uncorrected near vision of 20/40.
Exclusion criteria:
Inability to perform the tests
Strabismus
Moderate and severe Amblyopia
Significant ocular disease
Surgery or drug treatments for Presbyopia
Individuals with any systemic disease associated with Presbyopia or use of drugs (continuous or long-term)
Age
From 40 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The examiner (researcher) does not know which group the patient is placed in. Patients are informed about both methods after an initial assessment. Assignment to each group is determined by the patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Before training and glasses, first month after training, second month after training and glasses
Method of measurement
Push-up and minus lens methods
2
Description
Positive and Negative relative accommodation
Timepoint
Before training and glasses, first month after training, second month after training and glasses
Method of measurement
Positive and negative lenses
3
Description
Accommodative facility
Timepoint
Before training and glasses, first month after training, second month after training and glasses
Method of measurement
Flipper lens
4
Description
Symptoms
Timepoint
Before training and glasses, first month after training, second month after training and glasses
Method of measurement
Asthenopia Questionnaire (ASQ-17)
Secondary outcomes
1
Description
Far and Near visual acuity
Timepoint
Before starting training and glasses, one month after training, two months after training and glasses
Method of measurement
Distance and Near vision chart
2
Description
Refractive Errors
Timepoint
Before starting training and glasses, one month after training, two months after training and glasses
Method of measurement
Autorefractometer, Retinoscope and Subjective refraction
3
Description
Near addition power
Timepoint
Before starting training and glasses, one month after training, two months after training and glasses
Method of measurement
Subjective refraction
Intervention groups
1
Description
Intervention group: Accommodative training.The Hart chart exercises, far to near accommodative rock (5 minutes), Push-ups and Push-downs (5 minutes), Flipper lense, and Loose rock lenses (5 minutes) will be performed 5 days a week for 15 minutes a day for two months to improve amplitude and faccility of accommodation.
Category
Rehabilitation
2
Description
Control group: Glasses for near vision.Glasses are used for precise activities at close range, and the duration of use depends on the duration of the individual's visual work.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Optometry office
Full name of responsible person
Azam Abdollahi
Street address
No. 26, District 4, Mohammadiyeh City, Qazvin.
City
Mohammadiyeh
Province
Qazvin
Postal code
3491759789
Phone
+98 28 3257 2540
Email
azaabd98@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
6th Floor, Building No. 2, University Headquarters , Shahid Beheshti University of Medical Sciences and Health Services, Arabi Street, Yemen Street, Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۱۵۷۷۳۴۱۱
Phone
+98 21 2243 9780
Email
urm@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Abdollahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Optometry
Street address
Department of Optometry, Faculty of Rehabilitation, Shahid Beheshti University of Medical Sciences, Damavand Street, Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
azaabd98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Abdollahi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Optometry
Street address
Department of Optometry, Faculty of Rehabilitation, Shahid Beheshti University of Medical Sciences, Damavand Street, Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
azaabd98@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Abdollahi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Optometry
Street address
Department of Optometry, Faculty of Rehabilitation, Shahid Beheshti University of Medical Sciences, Damavand Street, Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
azaabd98@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
Yes - There is a plan to make this available
Title and more details about the data/document
Data can be shared after anonymizing participants and maintaining privacy.
When the data will become available and for how long
Data access begins 6 months after results are published.
To whom data/document is available
For researchers
Under which criteria data/document could be used
Data can be requested with a valid academic email.Use of data or data analysis without coordination is not permitted.
From where data/document is obtainable
Data can be requested with a valid academic email.
Azam Abdollahi
azaabd98@gmail.com
abdollahi@sbmu.ac.ir
What processes are involved for a request to access data/document
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