Table 3 Secondary Outcome to Investigate Efficacy of Treatment
3 Month Visit | 12 Month Visit | 18 Month Visit | |
|---|---|---|---|
N = 14 | N = 14 | N = 13a | |
Efficacy Outcome – n (%), (95% CI) | |||
Complete Success | 7 (50%), (23%, 77%) | 11 (79%), (49%, 95%) | 10 (77%), (46%, 95%) |
Partial Success | 5 (36%), (13%, 65%) | 2 (14%), (2%, 43%) | 2 (15%), (2%, 45%) |
Not a Success | 2 (14%), (2%, 43%) | 1 (7%), (0.2%, 34%) | 1 (8%), (0.2%, 36%) |
Component Measures of Efficacy– n (%), (95% CI) | |||
Improvement in corneal surface integrity | |||
Decrease in epithelial defect surface area by ≥75%b | 2 (50%), (7%, 93%) | 3 (75%), (19%, 99%) | 4 (100%), (40%, 100%) |
Decrease in cornea surface staining score by ≥50% | 8 (57%), (29%, 82%) | 11 (79%), (49%, 95%) | 10 (77%), (46%, 95%) |
Decrease in neovascular area by ≥25% | 12 (86%), (57%, 98%) | 11 (79%), (49%, 95%) | 10 (77%), (46%, 95%) |
Decrease in either symptom score by ≥25% | 9 (64%), (35%, 87%) | 9 (64%), (35%, 87%) | 10 (77%), (46%, 95%) |
Efficacy Outcome Definition 1.“Complete Success” is defined as improvement in corneal surface integrity 2. “Partial Success” is defined as a. No improvement in corneal surface integrity and b. Improvement in either i. Extent of corneal vascularization or ii. Participant symptomatology 3. Otherwise, “Not a Success” | |||
Improvement in each area is defined as follows, where changes are measured relative to baseline: • Corneal surface integrity ∘ If epithelial defect present at baseline, then improvement is defined as: ▪ Decrease in epithelial defect surface area by ≥75% (based on clinical assessment by an independent investigator, not the treating surgeon) ∘If no epithelial defect present at baseline, then improvement is defined as: ▪No epithelial defect and ▪ Decrease in corneal surface staining by ≥50% (based on clinical assessment by an independent investigator, not the treating surgeon, using NEI grading scale) • Extent of corneal vascularization ∘ Decrease in neovascular area ≥25% (based on digital slit lamp photographs, using mathematical software to calculate) • Participant symptomatology ∘ Decrease in Ocular Surface Disease Index (OSDI) score ≥25% or ∘ Decrease in Symptom Assessment in Dry Eye (SANDE) score ≥25% | |||
