CataractNCT05958459
The Effect of Eye Exercises on Visual Function and Quality of Life After Multifocal Intraocular Lens Implantation
A study testing Eye Exercise in people with Cataract and Intraocular Lenses, run by Idrıs Dogan.
Trial summary
The goal of this clinical trial is to examine the effects of eye exercises on visual function and quality of life in cataract patients undergoing multifocal intraocular lens implantation. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract, Intraocular Lenses
- What is being tested?
- Eye Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 4 Aug 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who can read,
- To adapt to the training program,
- To be involved in working voluntarily,
Who cannot join
- Individuals with a history of eye surgery,
- Being diagnosed with strabismus,
- Being diagnosed with glaucoma,
- Having a history of neurological disease that will affect vision and eye muscles,
- Having retinal and visual pathway damage,
- Having functional damage that will prevent the practice of exercises.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Eye Exercises for the Stimulation of Neuroadaptation After Multifocal Intraocular Lens Implantation on Visual Function and Quality of Life
The goal of this clinical trial is to examine the effects of eye exercises on visual function and quality of life in cataract patients undergoing multifocal intraocular lens implantation. The main questions it aims to answer are:
- Does it improve visual functions?
- Does it improve vision-related quality of life?
Participants in the intervention group will perform 8-step eye exercises at least once a day for 12 weeks. The control group will not practice, they will only be evaluated.
Read the detailed description
This is a randomized controlled clinical trial to be performed on individuals implanted with multifocal intraocular lenses. Necessary permissions were obtained from Hasan Kalyoncu University Non-Interventional Research Ethics Committee, Private Batman Dunya and Private Batman MedicalPoint Hospitals for the study. Participants will be selected from patients who are scheduled for multifocal intraocular lens implantation in the ophthalmology units of the relevant hospitals, who agree to volunteer and sign an informed consent form.
The individuals participating in the study will be randomly divided into two groups as the study group and the control group. Participants will be evaluated for a total of 3 times: before the surgery, at the 1st and 3rd months after the surgery. The number of group participants will be determined according to the power analysis of the data obtained in the first evaluation and considering data loss.
DATA TO BE COLLECTED:
- Demographic information (name, surname, contact information, age, weight, height, occupation, education level, CV, family history, medication, etc.),
- Refractive errors (Astigmatism, myopia, etc.),
- Near, medium, far visual acuity (Snellen Chart),
- Contrast sensitivity (Pelli-Robson contrast sensitivity chart),
- Pupillary Diameter,
- Intraocular pressure,
- Reading speed,
- Vision-related quality of life (National Institute of Eye Health Visual Function Scale (NEI-VFQ-25),
- Anxiety level (State and Trait Anxiety Scale),
- Cognitive performance (Standardized Mini Mental Test).
Refraction errors, visual acuity (near, intermediate and far), contrast sensitivity, intraocular pressure and pupil diameter will be evaluated by the ophthalmologist.
The individuals in the study group will perform home-based eye exercises for at least 1 session (~30 min.) every day for a total of 12 weeks, after the patient's condition is stable, starting from the 7th day after the surgery. After the initial assessment, participants will be given illustrated brochures describing the exercises and will be taught how to perform the exercises. Whether individuals comply with the exercise program will be closely monitored (by keeping a diary, online meetings and periodically calling individuals). The control group, on the other hand, will not perform any exercise, but will only be evaluated. Eye exercises include eight steps. These; Covering the eyes with the palm of the hand, blinking, lateral gaze, anterior and lateral gaze, rotational gaze, up-down gaze, nasal tip gaze, and near and far gaze.
- Closing the eyes with the palms; It helps to correct visual defects by stimulating eye muscles and stimulating aqueous humor circulation.
- Blinking; It supports the spontaneous realization of eye reflexes and helps to relax the eye muscles.
- sideways view; It relieves the tension of the eye muscles caused by close work and continuous reading and helps to correct strabismus.
- Front and side view; It regulates the coordination of the medial and lateral eye muscles.
- rotational view; regulates the balance of coordinated and peripheral movements of each eyeball.
- Up and down view; Balances the upper and lower eye muscles.
- Looking at the tip of the nose; It helps to focus the eye muscles and provide accommodation.
- Finally, the near and far gaze is similar to the nose tip, but the range of motion is wider.
- Conditions
- Cataract, Intraocular Lenses
- Being tested
- Eye Exercise, no intervention
- Keywords
- Cataract, Eye Exercises, Neuroadaptation, Intraocular Lens, Life quality, visual function
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye ExerciseOther
The individuals in the study group will perform home-based eye exercises for at least 1 session (~30 min.) every day for a total of 12 weeks, after the patient's condition is stable, starting from the 7th day after the surgery. After the initial assessment, participants will be given illustrated brochures describing the exercises and will be taught how to perform the exercises. Whether individuals comply with the exercise program will be closely monitored (by keeping a diary, online meetings and periodically calling individuals). The control group, on the other hand, will not perform any exercise, but will only be evaluated. Eye exercises include eight steps. These; Covering the eyes with the palm of the hand, blinking, lateral gaze, anterior and lateral gaze, rotational gaze, up-down gaze, nasal tip gaze, and near and far gaze.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | The individuals in the study group will perform home-based eye exercises for at least 1 session (~30 min.) every day for a total of 12 weeks, after the patient's condition is stable, starting from the 7th day after the surgery. After the initial assessment, participants will be given illustrated brochures describing the exercises and will be taught how to perform the exercises. Whether individuals comply with the exercise program will be closely monitored (by keeping a diary, online meetings and periodically calling individuals). Eye exercises include eight steps. These; Covering the eyes with the palm of the hand, blinking, lateral gaze, anterior and lateral gaze, rotational gaze, up-down gaze, nasal tip gaze, and near and far gaze. Receives: Other: Eye Exercise |
| control group | Experimental | The control group, on the other hand, will not perform any exercise, but will only be evaluated. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast Sensitivity
The Pelli-Robson contrast sensitivity test is a wall chart measuring 90 X 60 cm. The chart comprises 8 lines of letters with different contrasts. Each line has 6 letters; the first 3 letters (a triplet) on the left have more contrast than the 3 letters on the right. The contrast also decreases downward from line to line. The size of the letters is 4.9 X 4.9 cm. There are different sets of letters on each side of the chart. It recommends a test distance of 1 m. The logarithmic contrast sensitivity value of the last triplet of which at least 2 letters are correctly seen is marked as the result. The luminance of the test should be 85 candelas/m2 (cd/m2 ); the accepted range is 60 to 120 cd/m2.
Measured: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
Visual acuity
Snellen chart will be used for visual acuity measurement.
Measured: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
Vision-related quality of life
The National Institute of Eye Health Visual Function Scale (NEI-VFQ-25) will be used. This scale is used to evaluate visual function loss due to eye diseases and was developed by Mangione et al. in 1988. In order to make this scale, whose original form consists of 51 questions, more useful, a 25-question form was developed. The short form of 25 questions consists of 3 parts. These sections are respectively; general health and vision, difficulties with activities, and the consequences of vision problems.
Measured: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
Secondary outcomes (4)
Refraction errors
The refraction defects were measured by autorefractometry, which is frequently used because it provides fast and reliable results in clinic. In the autorefractometry method, the infrared rays sent to the patient's eye are reflected from the retina back to the device and evaluate the refraction defect of the patient
Measured: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
İntraocular Pressure
It will be measured with the Reichert 7CR Automatic Non Contact Tonometer device.
Measured: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
Pupillary diameter
will be evaluated using optical biometry.
Measured: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
Reading speed
Written material prepared in Times New Roman font and 12 point size will be read to the participant for one minute under appropriate lighting. At the end of the one-minute reading period, correctly read and incorrectly read words will be counted. The numerical value obtained by subtracting the number of words read incorrectly from the number of words read correctly will be used as a measure of the participant's reading speed.
Measured: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start4 Aug 2023 (estimated)
- Primary completion25 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Idrıs Dogan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Idrıs Dogan, Batman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958459
- Sponsor's protocol ID
- DR-DOGAN-001
- Status last verified
- Jul 2023
- First submitted
- 5 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Eye Exercises for the Stimulation of Neuroadaptation After Multifocal Intraocular Lens Implantation on Visual Function and Quality of Life
- ClinicalTrials.gov ID
- NCT05958459
- Acronym / sponsor ID
- DR-DOGAN-001
- Conditions
- Cataract, Intraocular Lenses
- Keywords
- Cataract, Eye Exercises, Neuroadaptation, Intraocular Lens, Life quality, visual function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Idrıs DoganUniversity, hospital or other
- Study start
- 4 Aug 2023 (estimated)
- Primary completion
- 25 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to examine the effects of eye exercises on visual function and quality of life in cataract patients undergoing multifocal intraocular lens implantation. The main questions it aims to answer are:
- Does it improve visual functions?
- Does it improve vision-related quality of life?
Participants in the intervention group will perform 8-step eye exercises at least once a day for 12 weeks. The control group will not practice, they will only be evaluated.
Detailed description
This is a randomized controlled clinical trial to be performed on individuals implanted with multifocal intraocular lenses. Necessary permissions were obtained from Hasan Kalyoncu University Non-Interventional Research Ethics Committee, Private Batman Dunya and Private Batman MedicalPoint Hospitals for the study. Participants will be selected from patients who are scheduled for multifocal intraocular lens implantation in the ophthalmology units of the relevant hospitals, who agree to volunteer and sign an informed consent form.
The individuals participating in the study will be randomly divided into two groups as the study group and the control group. Participants will be evaluated for a total of 3 times: before the surgery, at the 1st and 3rd months after the surgery. The number of group participants will be determined according to the power analysis of the data obtained in the first evaluation and considering data loss.
DATA TO BE COLLECTED:
- Demographic information (name, surname, contact information, age, weight, height, occupation, education level, CV, family history, medication, etc.),
- Refractive errors (Astigmatism, myopia, etc.),
- Near, medium, far visual acuity (Snellen Chart),
- Contrast sensitivity (Pelli-Robson contrast sensitivity chart),
- Pupillary Diameter,
- Intraocular pressure,
- Reading speed,
- Vision-related quality of life (National Institute of Eye Health Visual Function Scale (NEI-VFQ-25),
- Anxiety level (State and Trait Anxiety Scale),
- Cognitive performance (Standardized Mini Mental Test).
Refraction errors, visual acuity (near, intermediate and far), contrast sensitivity, intraocular pressure and pupil diameter will be evaluated by the ophthalmologist.
The individuals in the study group will perform home-based eye exercises for at least 1 session (~30 min.) every day for a total of 12 weeks, after the patient's condition is stable, starting from the 7th day after the surgery. After the initial assessment, participants will be given illustrated brochures describing the exercises and will be taught how to perform the exercises. Whether individuals comply with the exercise program will be closely monitored (by keeping a diary, online meetings and periodically calling individuals). The control group, on the other hand, will not perform any exercise, but will only be evaluated. Eye exercises include eight steps. These; Covering the eyes with the palm of the hand, blinking, lateral gaze, anterior and lateral gaze, rotational gaze, up-down gaze, nasal tip gaze, and near and far gaze.
- Closing the eyes with the palms; It helps to correct visual defects by stimulating eye muscles and stimulating aqueous humor circulation.
- Blinking; It supports the spontaneous realization of eye reflexes and helps to relax the eye muscles.
- sideways view; It relieves the tension of the eye muscles caused by close work and continuous reading and helps to correct strabismus.
- Front and side view; It regulates the coordination of the medial and lateral eye muscles.
- rotational view; regulates the balance of coordinated and peripheral movements of each eyeball.
- Up and down view; Balances the upper and lower eye muscles.
- Looking at the tip of the nose; It helps to focus the eye muscles and provide accommodation.
- Finally, the near and far gaze is similar to the nose tip, but the range of motion is wider.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: Eye ExerciseThe individuals in the study group will perform home-based eye exercises for at least 1 session (~30 min.) every day for a total of 12 weeks, after the patient's condition is stable, starting from the 7th day after the surgery. After the initial assessment, participants will be given illustrated brochures describing the exercises and will be taught how to perform the exercises. Whether individuals comply with the exercise program will be closely monitored (by keeping a diary, online meetings and periodically calling individuals). Eye exercises include eight steps. These; Covering the eyes with the palm of the hand, blinking, lateral gaze, anterior and lateral gaze, rotational gaze, up-down gaze, nasal tip gaze, and near and far gaze. |
| control group | Experimental | Other: no interventionThe control group, on the other hand, will not perform any exercise, but will only be evaluated. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals who can read,
- To adapt to the training program,
- To be involved in working voluntarily,
Key exclusion criteria (6 listed)
- Individuals with a history of eye surgery,
- Being diagnosed with strabismus,
- Being diagnosed with glaucoma,
- Having a history of neurological disease that will affect vision and eye muscles,
- Having retinal and visual pathway damage,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye ExerciseThe individuals in the study group will perform home-based eye exercises for at least 1 session (~30 min.) every day for a total of 12 weeks, after the patient's condition is stable, starting from the 7th day after the surgery. After the initial assessment, participants will be given illustrated brochures describing the exercises and will be taught how to perform the exercises. Whether individuals comply with the exercise program will be closely monitored (by keeping a diary, online meetings and periodically calling individuals). The control group, on the other hand, will not perform any exercise, but will only be evaluated. Eye exercises include eight steps. These; Covering the eyes with the palm of the hand, blinking, lateral gaze, anterior and lateral gaze, rotational gaze, up-down gaze, nasal tip gaze, and near and far gaze. | Other | study group |
| no interventionno intervention | Other | control group |
Primary outcome
Contrast Sensitivity
Time frame: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
The Pelli-Robson contrast sensitivity test is a wall chart measuring 90 X 60 cm. The chart comprises 8 lines of letters with different contrasts. Each line has 6 letters; the first 3 letters (a triplet) on the left have more contrast than the 3 letters on the right. The contrast also decreases downward from line to line. The size of the letters is 4.9 X 4.9 cm. There are different sets of letters on each side of the chart. It recommends a test distance of 1 m. The logarithmic contrast sensitivity value of the last triplet of which at least 2 letters are correctly seen is marked as the result. The luminance of the test should be 85 candelas/m2 (cd/m2 ); the accepted range is 60 to 120 cd/m2.
Visual acuity
Time frame: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
Snellen chart will be used for visual acuity measurement.
Vision-related quality of life
Time frame: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
The National Institute of Eye Health Visual Function Scale (NEI-VFQ-25) will be used. This scale is used to evaluate visual function loss due to eye diseases and was developed by Mangione et al. in 1988. In order to make this scale, whose original form consists of 51 questions, more useful, a 25-question form was developed. The short form of 25 questions consists of 3 parts. These sections are respectively; general health and vision, difficulties with activities, and the consequences of vision problems.
4 secondary outcomes
Refraction errors
Time frame: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
İntraocular Pressure
Time frame: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
Pupillary diameter
Time frame: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
Reading speed
Time frame: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Exercise in people with Cataract and Intraocular Lenses, run by Idrıs Dogan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İdris DOĞAN (+905367493050, idris.dogan@batman.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast Sensitivity (time frame: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.