Characteristics and outcomes of controlled clinical trials on autologous serum eye drop therapy in dry eye syndrome (DES)
| Study | Reference | Underlying diagnoses | Number of eyes/patients | Masking | Placebo | Dilution (%) | Frequency | Treatment length | Concurrent therapy | Objective tests | Subjective tests |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Tananuvat et al9 | SS, NHL, GVHD, SJS, RA | 24/12 | Single (patient) | Unpreserved saline solution (with dilute fluorescein) | 20 | 6×/day | 2 months | Punctal occlusion, PFAT | TBUT, RBS, FS, CIC | Symptom score |
| 2 | Noble et al10 | GVHD, SS, OCP, BS, RDS | 31/16 | Pathologist conducting CIC only | Pt’’s previous conventional treatment | 50 | Varied | 3 months | None | RBS, FCT, CIC | Faces Scale |
| 3 | Kojima et al11 | SS, non-SS | 37/20 | Examiner only | PFAT | 20 | 6×/day | 2 weeks | None | TBUT, RBS, FS, CIC | Visual analogue pain symptom score |
| 4 | Noda-Tsuruya et al45 | Post-LASIK dry eyes | 54/27 | N/A | Artificial tears | 20 | 5×/day | 6 months | None | TBUT, RBS, FS | Subjective scores |
| 5 | Urzua et al12 | Non-SS severe DES, age-related dry eye | 12 pts | Double-masked | Artificial tears | 20 | 4×/day | 2 weeks | None | TBUT, FS | OSDI score |
| 6 | Celebi et al13 | Severe DES | 40/20 | Double-masked | PFAT | 20 | 4×/day | 1 month | None | TBUT, Schirmer, Oxford score | OSDI score |
| Study | Reference | Objective improvement | Subjective improvement | Failure rate | Complications |
|---|---|---|---|---|---|
| 1 | Tananuvat et al9 | 33% (RB), 39% (FS) | 36% (symptom score) | N/A | 1 bottle positive cultures, 2 conjunctivitis pts |
| 2 | Noble et al10 | 48% of pts (CIC) | 75% of pts | 3/16 pts—objective (19%), 13/25 eyes—subjective (52%) | None |
| 3 | Kojima et al11 | TBUT, RB and FS scores statistically improved in tx group | Statistically significant improvement after treatment | N/A | Not mentioned |
| 4 | Noda-Tsuruya et al45 | TBUT prolonged @ 6 months, RB @ 1 and 3 months, FS @ 1 month | No difference before/after surgery | N/A | N/A |
| 5 | Urzua et al12 | No significant improvement in TBUT/FS | 50.95% decrease in OSDI (statistically sig.) | N/A | None |
| 6 | Celebi et al13 | TBUT improved significantly, OXFORD and Schirmer’s did not | 54.74% decrease in OSDI score (stat. sig.) | N/A | None |
BS, Behçet’s syndrome; CIC, conjunctival impression cytology; FCT, fluorescein clearance test; FS, fluorescein staining; GVHD, graft-versus-host disease; LASIK, laser-assisted in situ keratomileusis; NHL, non-Hodgkins lymphoma; OCP, ocular cicatricial pemphigoid; OSDI, Ocular Surface Disease Index; PFAT, preservative-free artificial tears; RA, rheumatoid arthritis; RBS, rose-bengal staining; RDS, Riley-Day syndrome; SJS, Stevens-Johnson syndrome; SS, Sjögren's syndrome; TBUT, tear break-up time.