Back to resultsOcular Surface Syndrome Post-lasik, Outcomes of Treatment With Platelet Rich Plasma (PRP-OSS)
Primary Purpose
Dry Eye After LASIK-Laser in Situ Keratomileusis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PRP autologous
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye After LASIK-Laser in Situ Keratomileusis focused on measuring dry eye, PRP, autologous, after LASIK, ocular surface
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
Full Information
NCT ID
NCT03322917
First Posted
October 18, 2017
Last Updated
December 1, 2017
Sponsor
Vissum, Instituto Oftalmológico de Alicante
1. Study Identification
Unique Protocol Identification Number
NCT03322917
Brief Title
Ocular Surface Syndrome Post-lasik, Outcomes of Treatment With Platelet Rich Plasma
Acronym
PRP-OSS
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2008 (Actual)
Primary Completion Date
January 17, 2013 (Actual)
Study Completion Date
January 17, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vissum, Instituto Oftalmológico de Alicante
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye After LASIK-Laser in Situ Keratomileusis
Keywords
dry eye, PRP, autologous, after LASIK, ocular surface
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Prospective interventional non-comparative consecutive case series.
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
PRP autologous
Intervention Description
Autologous platelet rich plasma: 1 drop / 6 times a day during 6 weeks
Primary Outcome Measure Information:
Title
Corneal fluorescein staining (CFS)
Description
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.
Time Frame
Before LASIK surgery and after the 6 weeks of treatment
Secondary Outcome Measure Information:
Title
Dry eye symptoms
Description
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.
Time Frame
Before LASIK surgery and after the 6 weeks of treatment
Title
Corrected distance visual acuity (CDVA)
Description
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.
Time Frame
Before LASIK surgery and after the 6 weeks of treatment
Title
Conjunctival hyperemia
Description
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).
Time Frame
Before LASIK surgery and after the 6 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JORGE L ALIO, DR.
Organizational Affiliation
Vissum, Instituto Oftalmológico de Alicante
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29379652
Citation
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.
Results Reference
derived
Learn more about this trial
Ocular Surface Syndrome Post-lasik, Outcomes of Treatment With Platelet Rich Plasma
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