Comparison of Efficacy Between 100% Platelet-rich Plasma and 100% Serum Eye Drops in Dry Eye Disease
Comparison of Efficacy Between 100% Platelet-rich Plasma and 100% Serum Eye Drops in Dry Eye Disease
Dry eye disease (DED) is a common eye problem, affecting 5% to 50% of the world population.
 Although the disease is not fatal, it substantially reduces quality of life and creates a
 high economic burden as high as over 50 billion from a societal perspective. Several
 biological tear substitutes (e.g., autologous serum (AS), autologous platelet rich plasma
 (APRP), and autologous platelet lysate (APL)) could effectively improve dry eyes, especially
 in patients with moderate to severe DED.. However, evidence on their comparative efficacy is
 controversial. The objective of the study is to compare the efficacy of 100% APRP with 100%
 AS eye drops in patients with moderate to severe DED.
The study is a single-center, double-blinded randomized, parallel, non-inferiority trial.
 Patients will be recruited from out-patient clinic, Department of Ophthalmology, Ramathibodi
 Hospital, Bangkok and will be randomized to receive either 100% APRP or 100% AS eye drops
 (1:1 ratio) for 4 weeks. The primary outcomes include ocular surface disease index (OSDI) and
 ocular surface staining evaluated using the Oxford scale. Secondary outcomes are fluorescein
 break-up time (FBUT), Schirmer's I test (ST I), meibomian gland parameters and adverse
 events.
Inclusion Criteria:

 -  Aged 18 to 70 years.

 -  Have OSDI scores ≥ 23 or Oxford staining grade ≥ 2.

 -  Do not have following conditions:

 Uncontrolled systemic diseases, active infection, advanced cancer. Pregnant and nursing
 women. • Have not recently used the following medications/interventions/surgery:
 Anticoagulants or anti-platelets. Topical undiluted blood products within 3 months. Punctal
 plug or contact lenses. Ocular surgery within 6 months.

 -  Do not have active ocular infection/inflammation, abnormal eyelid function or severe
 meibomian gland dysfunction (MGD stage 4).

 -  Have no contraindication for blood donations:

 Positive human immunodeficiency virus, hepatitis B or C, or syphilis. Anemia (Hb < 11 g/dL)
 or platelet concentration < 150,000/ml.

 -  Being able to stop current dry eye treatment for 48 hours before staring trial
 intervention

 -  Willing to comply with the 4-week study protocol and provide informed consent.

 Exclusion Criteria:

 • None