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

V

Vissum, Instituto Oftalmológico de Alicante

Status and phase

Completed
Phase 2

Conditions

Dry Eye After LASIK-Laser in Situ Keratomileusis

Treatments

Biological: PRP autologous

Study type

Interventional

Funder types

Other

Identifiers

NCT03322917
PRP-autologous/0208

Details and patient eligibility

About

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).

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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