This is a prospective, comparative, contralateral eye study. Patients older than 18 years who have had treatment with topical lubricants for at least 1 month and persist with symptoms of dry eye and corneal staining with fluorescein were included. Patients with dry eye attributable to abnormalities of the eyelids, nasolacrimal obstruction and active corneal infection, as well as patients with severe dry eye were excluded from the study. One eye randomly received a subcutaneous injection of botulinum toxin in the medial part of the lower eyelid, and the other eye received a similar procedure with placebo. The subjective evaluation was achieved with a questionnaire assessing symptoms of dry eye and conjunctivitis, quality of vision and ocular comfort level each eye separately. The objective evaluation included the measurement of the tear film break up time, Schirmer's test and with a modification of the Oxford grading scheme for corneal and conjunctival staining.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Injection of botulinum toxin type A
Injection of saline solution
Symptoms of dry eye (questionnaire)
A questionnaire assessing symptoms of dry eye each eye separately, including dryness, watery eyes, itching, burning, foreign body, fluctuating vision and light sensitivity. Depending on the frequency, each symptom will be graded from 0 to 5.
Time frame: 6 months
Symptoms of conjunctivitis (questionnaire)
A questionnaire assessing symptoms of conjunctivitis eye separately, including redness and discharge. Depending on the frequency, each symptom will be graded from 0 to 5.
Time frame: 6 months
Quality of vision (graded perception of patient)
The quality of vision will be graded from 0 to 5 according to the perception of the patient.
Time frame: 6 months
Ocular comfort level (graded perception of patient)
The ocular comfort level will be graded from 0 to 5 according to the perception of the patient.
Time frame: 6 months
Moisturizing agent usage (patient will be asked how many times a day does he use the moisturizing agent and will be graded from 0 to 5 according to the frequency)
The
Time frame: 6 months
Visual acuity (Snellen vision acuity)
Snellen vision acuity
Time frame: 6 months
Measurement of the tear film break up time (After fluorescein staining, the time required for dry spots to appear on the corneal surface after blinking)
After fluorescein staining, the time required for dry spots to appear on the corneal surface after blinking will be recorded in seconds.
Time frame: 6 months
Schirmer's test
After instillation of topical anesthetic, paper strips are inserted into the conjunctival sac for 5 minutes to measure the production of tears in millimeters.
Time frame: 6 months
Oxford grading scheme for corneal and conjunctival staining
After fluorescein staining, the corneal and conjunctival staining will be graded according to severity from 0 to 5.
Time frame: 6 months
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