Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Demographic information |
name, surname, contact information, age, weight, height, occupation, education level, CV, family history, medication, etc. |
Only on the first assessment (through study completion, an average of 12 week) |
|
| Other |
anxiety level (State Trait Anxiety Inventory I-II) |
The response options collected in four classes in the state anxiety scale are (1) Not at all, (2) A little, (3) A lot, and (4) Completely; The options in the Trait Anxiety Scale are (1) Almost never, (2) Sometimes, (3) Often, and (4) Almost always. There are two kinds of expressions in the scales. We can call these (1) direct or straight statements and (2) inverted statements. Direct expressions, negative emotions; reversed expressions express positive emotions. When scoring this second type of statements, those with a weight of 1 turn into 4, and those with a weight of 4 turn into 1. In direct statements, answers with a value of 4 indicate high anxiety. In reversed statements, answers with a value of 1 indicate high anxiety, and those with a value of 4 indicate low anxiety. The scores obtained from both scales theoretically vary between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety. |
12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.) |
|
| Other |
cognitive performance |
Standardized Mini Mental Test will be used. |
Only on the first assessment (through study completion, an average of 12 week) |
|
| Primary |
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.) |
|
| Primary |
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.) |
|
| Primary |
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 |
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 |
12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.) |
|
| Secondary |
Intraocular Pressure |
It will be measured with the Reichert 7CR Automatic Non Contact Tonometer device. |
12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.) |
|
| Secondary |
Pupillary diameter |
will be evaluated using optical biometry. |
12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.) |
|
| Secondary |
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. |
12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.) |
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