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
1 other identifier
interventional
80
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2008
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2013
CompletedFirst Submitted
Initial submission to the registry
October 18, 2017
CompletedFirst Posted
Study publicly available on registry
October 26, 2017
CompletedDecember 4, 2017
December 1, 2017
4.6 years
October 18, 2017
December 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Dry eye symptoms
Before LASIK surgery and after the 6 weeks of treatment
Corrected distance visual acuity (CDVA)
Before LASIK surgery and after the 6 weeks of treatment
Conjunctival hyperemia
Before LASIK surgery and after the 6 weeks of treatment
Interventions
Autologous platelet rich plasma: 1 drop / 6 times a day during 6 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29379652DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JORGE L ALIO, DR.
Vissum, Instituto Oftalmológico de Alicante
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2017
First Posted
October 26, 2017
Study Start
July 1, 2008
Primary Completion
January 17, 2013
Study Completion
January 17, 2013
Last Updated
December 4, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share