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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-01

Study Completion Date

2013-01-17

Brief Summary

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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

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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.

Conditions

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Dry Eye After LASIK-Laser in Situ Keratomileusis

Keywords

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dry eye PRP autologous after LASIK ocular surface

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective interventional non-comparative consecutive case series.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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PRP autologous

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JORGE L ALIO, DR.

Role: PRINCIPAL_INVESTIGATOR

Vissum, Instituto Oftalmológico de Alicante

References

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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.

Reference Type DERIVED

PMID: 29379652 (View on PubMed)

Other Identifiers

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PRP-autologous/0208

Identifier Type: -

Identifier Source: org_study_id