Clinical trial NCT05958459: The Effect of Eye Exercises on Visual Function and Quality of Life After Multifocal Intraocular Lens Implantation
Official title: The Effect of Eye Exercises for the Stimulation of Neuroadaptation After Multifocal Intraocular Lens Implantation on Visual Function and Quality of Life
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cataract
Intraocular Lenses
Keywords: Cataract
Eye Exercises
Neuroadaptation
Intraocular Lens
Life quality
visual function
Lead sponsor: Batman University
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Individuals who can read,
* To adapt to the training program,
* To be involved in working voluntarily,

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Contrast Sensitivity
timeFrame: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
measure: Visual acuity
timeFrame: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
measure: Vision-related quality of life
timeFrame: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
Secondary outcomes:
measure: Refraction errors
timeFrame: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
measure: İntraocular Pressure
timeFrame: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
measure: Pupillary diameter
timeFrame: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
measure: Reading speed
timeFrame: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
Other outcomes:
measure: Demographic information
timeFrame: Only on the first assessment (through study completion, an average of 12 week)
measure: anxiety level (State Trait Anxiety Inventory I-II)
timeFrame: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
measure: cognitive performance
timeFrame: Only on the first assessment (through study completion, an average of 12 week)
Locations:
Study officials:
References: