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Completed

NCT Number: NCT03322917

Ocular Surface Syndrome Post-lasik, Outcomes of 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).

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Key information

Conditions

Dry Eye After LASIK-Laser in Situ Keratomileusis Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRP autologous

Biological

Autologous platelet rich plasma: 1 drop / 6 times a day during 6 weeks

Primary outcomes

  1. Corneal fluorescein staining (CFS)

    Time frame: 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 outcomes

  1. Dry eye symptoms

    Time frame: 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.

  2. Corrected distance visual acuity (CDVA)

    Time frame: 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.

  3. Conjunctival hyperemia

    Time frame: 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).

    • = 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).

Sponsors and collaborators

Lead sponsor

Vissum, Instituto Oftalmológico de Alicante

Other

Registry information

Official study 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

Acronym: PRP-OSS

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Oct 26, 2017
Registry last updated
Dec 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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