The Effect of Eye Exercises on Visual Function and Quality of Life After Multifocal Intraocular Lens Implantation

NCT05958459 | Unknown

• 1 other identifier: DR-DOGAN-001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract; Intraocular Lenses

Keywords

Cataract; Eye Exercises; Neuroadaptation; Intraocular Lens; Life quality; visual function

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)

Secondary Outcomes (4)

• Refraction errors

  12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)

• İntraocular Pressure

  12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)

• Pupillary diameter

  12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)

• Reading speed

  12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)

Other Outcomes (3)

• Demographic information

  Only on the first assessment (through study completion, an average of 12 week)

• anxiety level (State Trait Anxiety Inventory I-II)

  12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)

• cognitive performance

  Only on the first assessment (through study completion, an average of 12 week)

Study Arms (2)

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.

Other: Eye Exercise

control group

EXPERIMENTAL

The control group, on the other hand, will not perform any exercise, but will only be evaluated.

Other: no intervention

Interventions

Eye Exercise OTHER

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.

study group

no intervention OTHER

no intervention

control group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idrıs Dogan: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

İdris DOĞAN

CONTACT

+905367493050; idris.dogan@batman.edu.tr

Yavuz YAKUT

CONTACT

+905324181001; yavuz.yakut@hku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 24, 2023
• Study Start: August 4, 2023
• Primary Completion: December 25, 2023
• Study Completion: January 1, 2024
• Last Updated: July 24, 2023

Record last verified: 2023-07