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To evaluate the efficacy of autologous platelet-rich plasma eye drops (E-PRP) for the treatment of chronic ocular surface syndrome (OSS) following laser in situ keratomileusis (LASIK).
Prospective interventional consecutive case series including 156 eyes of 80 patients affected by chronic post-LASIK OSS who were treated with autologous E-PRP 6 times a day as monotherapy for 6 weeks. Assessment after treatment with E-PRP included: dry eye symptoms, change in corrected distance visual acuity (CDVA), corneal fluorescein staining (CFS) and conjunctival hyperemia.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP autologous | Biological | Autologous platelet rich plasma: 1 drop / 6 times a day during 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal fluorescein staining (CFS) | Staining using fluorescein will be graded using the modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5 (see Appendix 2). On this modified scale, the score 0 corresponds to no staining dots and the score 0.5 to three or less staining dots. A CFS grade of 0 represents complete corneal clearing. A negative change from baseline will indicate improvement. | Before LASIK surgery and after the 6 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Dry eye symptoms | The symptoms of ocular discomfort (unrelated to instillation of the study medication), burning/stinging, foreign body sensation, eye dryness, pain, will be assessed for intensity by the study patients using a self-administered VAS ranging from 0% to 100%. The symptoms will be assessed separately for each eye and data from the worst eye will be used for analysis. A decrease in the VAS score from baseline will indicate improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JORGE L ALIO, DR. | Vissum, Instituto Oftalmológico de Alicante | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29379652 | Derived | Alio JL, Rodriguez AE, Abdelghany AA, Oliveira RF. Autologous Platelet-Rich Plasma Eye Drops for the Treatment of Post-LASIK Chronic Ocular Surface Syndrome. J Ophthalmol. 2017;2017:2457620. doi: 10.1155/2017/2457620. Epub 2017 Dec 12. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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Prospective interventional non-comparative consecutive case series.
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| Before LASIK surgery and after the 6 weeks of treatment |
| Corrected distance visual acuity (CDVA) | Best corrected distance visual acuity (BCDVA) will be measured using the LogMar scale. The patient is seated at 3 or 4 m from the EDTRS or modified EDTRS chart, depending on chart size and must try to read all letters first while covering the left eye, then while covering the right eye. | Before LASIK surgery and after the 6 weeks of treatment |
| Conjunctival hyperemia | Biomicroscopy will be performed using a slit lamp. The patient will be seated while being examined grading of the conjunctival hyperemia, according to the following scales: 0 = None (normal).
| Before LASIK surgery and after the 6 weeks of treatment |