Ocular Surface Syndrome Post-lasik, Outcomes of Treatment With Platelet Rich Plasma (PRP-OSS)

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

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).

Study Overview

• Status: Completed
• Conditions: Dry Eye After LASIK-Laser in Situ Keratomileusis
• Intervention / Treatment: Biological: PRP autologous

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vissum, Instituto Oftalmológico de Alicante
• Investigators: Principal Investigator: JORGE L ALIO, DR., Vissum, Instituto Oftalmológico de Alicante

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2008
• Primary Completion (Actual): January 17, 2013
• Study Completion (Actual): January 17, 2013

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (Actual): October 26, 2017

Study Record Updates

• Last Update Posted (Actual): December 4, 2017
• Last Update Submitted That Met QC Criteria: December 1, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: autologous; dry eye; ocular surface; PRP; after LASIK
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: PRP-autologous/0208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No