The purpose of this open controlled multicenter trial is to assess the impact of use of an amniotic membrane on post PKR recovery.
Photorefractive keratectomy (PRK) and laser-assisted in situ keratomileusis (LASIK) are two of the most widely used techniques of laser vision correction. However, one of the major disadvantages of the PRK technique is the pain experienced during 1 to 3 days after intervention. Preliminary data on a limited number of patients tend to show a reduction of pain, tearing and discomfort in patients for whom a amniotic membrane was used under a therapeutic lens.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
9
Therapeutic lens will be apposed on patient's dominant eye after bilateral PRK. Therapeutic lens will be maintained without interruption until the first postoperative visit when it will be removed by the surgeon.
Amniotic membrane (Visio-AMTRIX) will be apposed under therapeutic lens on patient's non-dominant eye after bilateral PRK. Amniotic membrane and therapeutic lens will be maintained without interruption until the first postoperative visit when it will be removed by the surgeon.
Clinique Vision Laser des Alpes
Grenoble, France
Centre Monticelli-Paradis d'Ophtalmologie
Marseille, France
CHU de Saint-Etienne Hôpital Nord
Saint-Priest-en-Jarez, France
Change of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS) in both eyes
Time frame: Day 1
Change of pain in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS) in both eyes
Time frame: 2 days, 3 days, 30 to 45 days
Change of visual discomfort in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
Evaluation by the patient of visual discomfort criteria; tearing, foreign body sensation, blurred vision, and photophobia; from 0: no discomfort to 10: worst imaginable discomfort on visual analog scale (VAS) in both eyes
Time frame: 1 day, 2 days, 3 days, 30 to 45 days
Identical healing of both eyes
Healing evaluated under slit lamp by fluorescein examination with measurement of ulcer size
Time frame: 2 or 3 days, 30 to 45 days
Better visual acuity in the eye treated with therapeutic lens + amniotic membrane (experimental) compared to eye treated with therapeutic lens alone (active comparator)
Determination of logMAR values of uncorrected visual acuity and best corrected visual acuity for both eyes
Time frame: 30 to 45 days
Rate of corneal haze for each treatment
Evaluation of presence of corneal haze through the Hanna's grading scale from grade 0: no haze to grade 4: very severe haze
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Time frame: 30 to 45 days