Efficacy of platelet rich plasma in dry eye patients who had not responded to autologous serum treatment

Phase 2

Recruiting

• Conditions: Dry eye disease; Platelet rich plasma; Ocular surface disease

• Registration Number: TCTR20201020002
• Lead Sponsor: Ratchadaphaiseksomphot fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-20
• Study Completion: 2021-12-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Aged 18-80 years
OSDI scores at least 13 with corneal staining > 5 spots or tear break-up time < or = 5 seconds in patients treated with autologous serum at least 3 months

Exclusion Criteria

Lid problems including lagophthalmos, ectropion, entropion trichiasis, distichiasis, epiblepharon
Previuos history of ocular infection in 3 months
Possibility to have problem with follow-up
Possibility to have problem with applying platelet rich plasm
Herpetic keratitis
Thrombocytopenia, sepsis, chronic liver disease, anti-coagulation therapy including warfarin, dabigatran, heparin
Hb < 11 mg/dl or Hct < 33% or platelet < 140,000 cell/mm2
History of ocular surgery within 1 month

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dry eye symptoms 1, 2, 3 months Ocular surface disease index score

Secondary Outcome Measures

Name	Time	Method
Corneal staining 1, 2, 3 months Cornea NEI scale,Conjunctival staining 1, 2, 3 months Conjunctival NEI scale,Tear break up time 1, 2, 3 months Tear break up time,Tear production 1, 2, 3 months Schirmer test,Subbasal and dendritic cell density 1, 2, 3 months In vivo confocal microscopy,Side effect 1 wk, 1, 2, 3 months description