Table 3.
Summary of the studies on the use of UCBS. Legend: Auto-SED = Autologous serum eye drops; AMT = Amniotic membrane transplantation; BSS: Balanced salt solution; CIC = Conjunctival impression cytology; CMC = Carboxymethylcellulose; d = day; DALK = Deep anterior lamellar keratoplasty; DED = Dry eye disease; FS = Fluorescein staining; GVHD = Graft versus host disease; I = interventional; ISS = Isotonic Saline Solution; LASEK = laser epithelial keratomileusis; M = Month; OSDI = Ocular Surface Disease Index; P = Prospective; PED = Persistent epithelial defects; PK = Penetrating Keratoplasty; RCT = randomized controlled trial; RBS = Rose Bengal staining; SS = Sjogren’s syndrome; ST = Schirmer test; TBUT = Tear Break Up Time; wks = weeks.
| Study First Name, Year | Evidence Level | Design | Condition | Inclusion Criteria | Patients (n) | Controls (n) | Control Arm | Solvent Composition | Dilution | Posology | Duration of Treatment | Main Outcomes | Results |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vajpayee 2003 [88] | 1 | RCT | PED | Refractory to treatments (tear substitute, patching, and contact lens) | 31 | 29 | Auto-SED | ISS | 20% | 6×/d | 3 wks | BCVA, FS, TBUT, ST, and PED size | Improvement of re-epithelization rate in UCBS group |
| Yoon 2005 [89] | 3 | P, I | PED | PED refractory to treatments; persisted for at least 2 weeks | 14 | / | / | ISS | 20% | 6×/d | 2 wks–1 M | PED area | 43% healing within 2 weeks; 43% healing within 4 weeks |
| Yoon 2006 [82] | 2 | P, I | DED | Refractory to treatments. DED symptoms > 3 months, TBUT < 5 s, ST < 5 mm/min, positive FS or RBS | 31 | / | / | ISS | 20% | 6–10×/d | 2 Ms | Subjective symptoms, TBUT, ST, corneal sensitivity, and FS | Improvement of symptoms, TBUT, and FS |
| Yoon 2007 [90] | 2 | P, I | DED | Refractory to treatments. DED symptoms > 3 months, TBUT < 5 s, ST < 5 mm/min, positive FS or RBS | 27 | 21 | Auto-SED | ISS | 20% | 6–10×/d | 2 Ms | Symptom scoring, corneal sensitivity, TBUT, ST, tear clearance rate, FS, and CIC | Symptoms, TBUT, FS, and CIC findings improved in both groups. Symptoms and FS were lower in the CBS group |
| Yoon 2007 [93] | 2 | P, I | DED (GVHD) | Refractory to treatments, TBUT < 5, ST < 5 mm/min, positive FS | 12 | / | / | ISS | 20% | 6–10×/d | 6 Ms | Subjective symptoms, TBUT, ST, corneal sensitivity test, FS, and tear clearance rate | Significant improvement in symptoms, corneal sensitivity, TBUT, and FS |
| Yoon 2007 [98] | 2 | P, non-comparative case series | NK | Refractory to treatment (tear substitute and contact lens) | 28 | / | / | ISS | 20% | 6×/d | 2–4 wks | Epithelial healing time, BCVA, and corneal sensitivity | 100% corneal healing after 4 weeks |
| Sharma 2011 [91] | 1 | RCT | Acute Chemical Burn | Acute chemical burns of grades III, IV, and V (Dua’s classification) | Group 1: 12 | Group 2: 11 Group 3: 10 |
Group 2: Auto-SED Group 3: Medical Treatment |
ISS | 20% | 10×/d | 3 Ms | Time to epithelialization, subjective symptoms, PED area, extent of limbal ischemia, corneal clarity, and symblepharon formation | Significant reduction of time to epithelialization after CBS therapy compared to AS and medical treatment |
| Yoon 2011 [94] | 2 | P, I, case-control | RCE | History of RCE | 18 | 17 | Tear substitute | ISS | 20% | 4–6×/d | 1 year | Number of recurrences | Reduction of recurrences in UCBS group |
| Versura 2013 [46] | 2 | P, I | PED (GVHD and SS) | DED symptoms, positive FS or RBS, ST < 5 mm/5 min or TBUT < 5 s | 30 | / | / | Phosphate buffered saline | 20% | 8×/d | 1 M | PED area, subjective symptom (OSDI), ST I, TBUT, tear osmolarity, corneal esthesiometry, and CIC | Significant reduction of epithelial damage |
| Yoon 2013 [96] | 2 | P, I, case-control | Epithelial defect post-LASEK | Patients underwent LASEK | 32 | 28 | Tear substitute | ISS | 20% | 4–6×/d | 3 Ms | Epithelial healing time, BCVA, Haze score (0–4), ST, and TBUT | Improvement of corneal haze and tear film parameters |
| Erdem 2014 [87] | 2 | P, I | PED | Refractory to treatment (tear substitute and patching contact lens) | 14 | / | / | ISS | 20% | 10×/d then 5x/d | 3 wks | PED area | 75% healing within 12 ds |
| Mukhopadhyay 2015 [97] | 1 | RCT | DED (Hansen’s disease) | ST < 5 mm/5 min | 48 | Group B: 52 Group C: 44 |
Group B: Auto-SED 20% Group C: Tear substitute |
ISS | 20% | 6–10×/d | 6 wks | Subjective symptom, ST I, TBUT, and CIC | Better improvement of clinical parameters in CBS group |
| Sharma 2016 [92] | 1 | RCT | Acute Chemical Burn | Acute chemical burns of grades III, IV, and V (Dua’s classification) | Group 3: 15 | Group 1: 15 Group 2: 15 |
Group 1: Medical treatment Group 2: AMT, Medical treatment |
/ | 20% | 10×/d | Open | Subjective symptoms, TBUT, and ST | UCS and AMT are equally efficacious |
| Giannaccare 2017 [86] | 2 | P, I | DED | DED symptoms, positive FS or RBS, ST < 5 mm/5 min or TBUT < 5 s | 20 | / | / | ISS | 20% | 8×/d | 4 Ms | Subjective symptom (OSDI), ST I, TBUT, FS, and corneal sensitivity | Significant improvement of all clinical parameters |
| Kamble 2017 [95] | 1 | RCT | Epithelial defect post-keratoplasty | Epithelial defect post PK and DALK | Group 1: 35 | Group 2: 35 Group 3: 35 |
Group 2: Auto-SED 20% Group 3: Tear substitute |
BSS | 20% | 6×/d | Until healing | Rate of re-epithelialization | Rate of re-epithelialization comparable between CBS and Auto-SED groups |