- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06729879
Effect of Yoga Eye Exercises and Musculoskeletal Physiotherapy Interventions on Presbyopia
Study Overview
Status
Conditions
Detailed Description
This study will be conducted by a permanent ophthalmologist from the Department of Ophthalmology at Tokat Gaziosmanpaşa University Hospital, before and after all evaluations. The ophthalmologist will be informed about the purpose and scope of the study, and in this direction, suitable individuals will be determined according to the criteria for inclusion or exclusion during eye examinations. These individuals will be given preliminary information and those who agree to participate in the study will be included in the study.Yoga eye exercises group: Yoga eye exercises include eight steps. These are; closing the eyes with the palms, blinking, sideways gaze, front and sideways gaze, rotational gaze, up and down gaze, gaze at the tip of the nose, and near and far gaze (1).It will be implemented as a home-based program every day for 8 weeks.Myofascial release-postural correction exercise group: In our study, a 15-minute myofascial release application is planned. For more efficient suboccipital release, a 5-minute upper trapezius muscle release will be applied beforehand and a 10-minute suboccipital release will be applied (2). A 15-minute application is planned, 3 times a week for 8 weeks.Neck exercise training will be applied face to face 3 times a week for 8 weeks and as a home program on other days.Yoga eye exercises, myofascial release-postural correction exercises group: People in this group will apply yoga eye exercises individually every day for 8 weeks and will be followed up once a week. People in this group will receive myofascial release treatment 3 days a week, postural correction exercises will be done together and they will be asked to do postural correction exercises on the remaining days.Control group: The control group will not receive any intervention and will receive initial evaluations and final evaluations after 8 weeks.Assessment tools; Demographic Information Form, which includes basic information about the participants in the study, Refraction Measurement, Visual Acuity Measurement, Accommodation Amplitude Evaluation, National Eye Health Institute Visual Function Scale (NEI-VFQ 25), Craniovertebral Angle Assessment and Reading Speed assessment will be performed.
References
- Kim SD. Effects of yogic eye exercises on eye fatigue in undergraduate nursing students. Journal of Physical Therapy Science. 2016;28(6):1813.
- Cho SH. The effect of suboccipital muscle inhibition and posture correction exercises on chronic tension-type headaches. Journal of Back and Musculoskeletal Rehabilitation. 2021;1:1-8.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: RUMEYSA BARUT, research asistant
- Phone Number: + 905455716032
- Email: rumeysa.barut@gop.edu.tr
Study Contact Backup
- Name: ZELİHA BAŞKURT, Professor Doctor
- Phone Number: + 902462113710
- Email: zelihabaskurt@sdu.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria Being between the ages of 40-65, Being diagnosed with presbyopia by an ophthalmologist, Having the mental capacity to understand and perform the exercises, Not having a systemic disease that prevents exercise, Agreeing to participate in the study
Exclusion Criteria; People with a history of eye surgery, People with refractive errors such as myopia, hyperopia, astigmatism, etc., People with a history of head-neck and upper extremity surgery, Being diagnosed with strabismus, Being diagnosed with glaucoma, Having a neurological problem affecting visual functions, Being diagnosed with cataract, Having a history of eye inflammation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: yoga eye exercises group
Yoga eye exercises include eight steps.
These are; closing the eyes with the palms, blinking, sideways gaze, front and sideways gaze, rotational gaze, up and down gaze, nose tip gaze, and near and far gaze.
After the initial evaluation, individuals will be taught how to perform the exercises and brochures describing the exercises will be given to the individuals.
It will be applied as a home-based program every day for 8 weeks.
|
Yoga eye exercises
|
|
Active Comparator: myofascial release and postural correction exercises group
In our study, it is planned to apply 15 minutes of myofascial release. It is planned to apply 15 minutes 3 times a week for 8 weeks. In our study, exercises for the neck will be applied as posture correction exercises. It will consist of a 20-30 minute program. After the first evaluation, the exercises will be done together and taught to the individuals and an exercise brochure will be given. Postural correction exercises will be done together on the treatment days when myofascial release is applied. On other days, the participant will be asked to do the postural correction exercises at home. Exercise training will be applied face to face 3 times a week for 8 weeks and as a home program on other days. |
Myofascial release-postural correction exercises
|
|
Placebo Comparator: yoga eye exercises and myofascial release-postural correction exercises group,
People in this group will practice yoga eye exercises individually every day for 8 weeks and will be followed up once a week.
People will be given brochures for the exercises and postural correction exercises in the yoga eye exercises group.
People in this group will receive myofascial release therapy 3 days a week, postural correction exercises will be done together and they will be asked to do postural correction exercises on their own on the remaining days.
|
Yoga eye exercises, myofascial release-postural correction exercises group
|
|
Sham Comparator: Control Group
The control group will not receive any intervention and will receive their first evaluation and final evaluations after 8 weeks.
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Refraction Measurement
Time Frame: 8 week
|
Refractive errors will be measured by the ophthalmologist using the autorefractometry method.
|
8 week
|
|
Craniovertebral Angle Assessment:
Time Frame: 8 week
|
Head posture will be assessed by measuring the craniovertebral angle.
The craniovertebral angle is the angle formed by the horizontal plane of the line connecting the midpoint of the ear tragus to the spinous process of C7.
A decrease in the craniovertebral angle indicates an increase in the anterior tilt position of the head.
The craniovertebral angle will be assessed by photographing while the patient is standing with equal weight on both feet.
A photograph will be taken from 1.5 meters away from the patient's shoulder level.
A marker will be attached to the spinous process of C7 and a photograph will be taken from the left shoulder level.
|
8 week
|
|
Visual Acuity Measurement
Time Frame: 8 week
|
The near reading chart prepared by Eğrilmez et al. based on logarithmic order will be used.
This chart is a Turkish near vision chart with 11 digits, each with a 0.1 LogMAR interval, where visual acuity can be measured from 1/10 (20/200) to 10/10 (20/20).
|
8 week
|
|
Evaluation of Accommodation Amplitude:
Time Frame: 8 week
|
To evaluate the accommodation amplitude (AA), the Tonoref III autorefractometer will be used.
The device measures the change in the pupil diameter from 3 to 8 mm in 1 mm increments.
It also measures AA from 0 to 10 D. Only the middle area is used for accommodation.
The measurement ends when there is no change in accommodation for more than 6 seconds or when the measurement time reaches 30 seconds.
|
8 week
|
|
National Eye Health Institute Visual Functioning Scale (NEI-VFQ 25)
Time Frame: 8 week
|
This scale is used to assess vision-related quality of life.
It consists of 3 sections with 25 questions.
These sections are; general health and vision, difficulties related to activities and results of vision problems.
Validity and reliability were done by Toprak et al.
Scores range from 0 to 100.
Increasing scores indicate an increase in vision-related quality of life.
|
8 week
|
|
Reading Speed Evaluation
Time Frame: 8 week
|
In order to evaluate reading performance, participants will be asked to read a text they have never encountered before out loud for one minute and their readings will be recorded.
The text will be an easy text without complex words and will be prepared using sentences with at least 2 and at most 10 words.
The entire text will be written in 18-point font with 3 lines between.
The total number of words read in one minute, regardless of whether they are correct or incorrect, will be considered as the reading speed .
|
8 week
|
|
Demographic Information Form
Time Frame: 8 week
|
A form containing questions about the socio-demographic characteristics of the participants (age, gender, height, weight, body mass index, education status, occupation) will be applied.
|
8 week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GaziosmanpasaUFizyoterapi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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