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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01933-38 | Other Identifier | IDRCB |
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Lack of apparent benefits
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic lens alone | Active Comparator |
| |
| Therapeutic lens + amniotic membrane (Visio-AMTRIX) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic lens alone | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Vision Laser des Alpes | Grenoble | 38000 | France | |||
| Centre Monticelli-Paradis d'Ophtalmologie |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Self-controlled trial: each patient serves as his or her own control. After bilateral PRK procedure, patients will receive both treatments, one treatment in each eye.
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| Therapeutic lens + amniotic membrane (Visio-AMTRIX) | Other | 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. |
|
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 |
| 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 | 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 | 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 | 30 to 45 days |
| Marseille |
| 13006 |
| France |
| CHU de Saint-Etienne Hôpital Nord | Saint-Priest-en-Jarez | 42270 | France |