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

Dry Eye After LASIK-Laser in Situ Keratomileusis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03322917
• Other study ID #: PRP-autologous/0208
• Status: Completed
• Phase: Phase 2
• First received: October 18, 2017
• Last updated: December 1, 2017
• Start date: July 1, 2008
• Est. completion date: January 17, 2013

Study information

• Verified date: December 2017
• Source: Vissum, Instituto Oftalmológico de Alicante
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 17, 2013
• Est. primary completion date: January 17, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye After LASIK-Laser in Situ Keratomileusis

Intervention

Biological:
• PRP autologous
Autologous platelet rich plasma: 1 drop / 6 times a day during 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vissum, Instituto Oftalmológico de Alicante

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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