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

Phase 2

Completed

• Conditions: Dry Eye After LASIK-Laser in Situ Keratomileusis

• Registration Number: NCT03322917
• Lead Sponsor: Vissum, Instituto Oftalmológico de Alicante

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-07-01
• Primary Completion: 2013-01-17
• Study Completion: 2013-01-17
• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-26
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-01
• Last Update Posted: 2017-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Corneal fluorescein staining (CFS)	Before LASIK surgery and after the 6 weeks of treatment	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.

Secondary Outcome Measures

Name	Time	Method
Conjunctival hyperemia	Before LASIK surgery and after the 6 weeks of treatment	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).; 1. = Mild (a flush reddish color predominantly confined to the palpebral or bulbar conjunctiva).; 2. = Moderate (more prominent red color of the palpebral or bulbar conjunctiva).; 3. = Severe (definite redness of palpebral or bulbar conjunctiva).
Corrected distance visual acuity (CDVA)	Before LASIK surgery and after the 6 weeks of treatment	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.
Dry eye symptoms	Before LASIK surgery and after the 6 weeks of treatment	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.