Ocular Surface Syndrome Post-lasik, Outcomes of Treatment With Platelet Rich Plasma

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Prospective Interventional Non-randomized and Non-comparative Series of Cases of Patiens Suffering Ocular Surface Syndrome Post-LASIK: Outcomes After the Treatment With Platelet Rich Plasma

Conditions
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Dry Eye After LASIK-Laser in Situ Keratomileusis

Intervention / Treatment
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* Biological: PRP autologous


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients suffering from moderate to severe dry eye syndrome for 6 months or more after conventional treatments with artificial tears following LASIK. Tear break-up time (TBUT) between 4 and 9 seconds. Exclusion Criteria: Ocular pathology needing topical treatments different than dry eye syndrome Trombocitopeny, associated pathologies to coagulation factors or any state of plaquets antiagregation (AAS and other AINES). Ocular tumours, corneal distrophies, history of ocular herpes. Pregnant or nursering women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective interventional non-comparative consecutive case series.
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: PRP autologous|Autologous platelet rich plasma: 1 drop / 6 times a day during 6 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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). = Mild (a flush reddish color predominantly confined to the palpebral or bulbar conjunctiva). = Moderate (more prominent red color of the palpebral or bulbar conjunctiva). = Severe (definite redness of palpebral or bulbar conjunctiva). | Before LASIK surgery and after the 6 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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after LASIK, PRP, dry eye, autologous, ocular surface