Al Zubi 2019.
Study characteristics | ||
Methods |
Study design: parallel‐group, randomized controlled trial
Number randomized (total and per group): 80 in total; 40 into each group Unit of randomization (individual or eye): individual (1 eye per participant) Number analyzed (total and per group): not explicitly reported Unit of analysis (individual or eye): individual (1 eye per participant) Exclusions and losses to follow‐up (total and per group): not explicitly reported How were missing data handled?: not reported Length of follow‐up: 12 months Reported power calculation (Y/N), if yes, sample size and power: not reported |
|
Participants |
Country: Jordan Setting: tertiary care Baseline characteristics Transepithelial CXL, n = 40
Epithelium‐off CXL, n = 40
Overall, n = 80
Inclusion criteria: "participants with keratoconus aged 18 years or above with documented progression of keratoconus (greater than 0.5D rise in six months or greater than 1 D rise in steep K/12months), keratometry (between 46 D and 56 D along with the corneal thickness being ≥400 μm) from the thinnest point, and no corneal scarring on presentation were included in this study" Exclusion criteria: none listed Baseline equivalence: it was unclear if participants were comparable at baseline. The authors reported: "While, mean Sim K astigmatism was 6.73 ± 1.98D in group 2 (range 4.3 D to 11.1 D). There was a significant difference between the two groups (P = 0.02)"; however, equivalent data in Table 2 showed a P value of 0.3. |
|
Interventions | 1. Transepithelial CXL
2. Epithelium‐off CXL
|
|
Outcomes |
Primary outcomes: CDVA, UDVA, central corneal thickness Secondary outcomes: keratometric astigmatism, flattest keratometry, steepest keratometry Adverse outcomes:
Measurement time points: 3, 6, and 12 months Other issues with outcome assessment (e.g. quality control for outcomes, if any): none |
|
Notes |
Study period: not reported Publication language: English Trial registration: not found Conflicts of interest: "The authors declare no conflict of interest, financial or otherwise" Funding source: "The authors declare no conflict of interest, financial or otherwise" |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | It was unclear what "odd‐even number allocation method, known as a randomized controlled trial" means: "the keratoconus patients were allocated to one of the two groups in a random fashion in accordance with the odd‐even number allocation method, known as a randomized control trial." |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment was unclear: "the keratoconus patients were allocated to one of the two groups in a random fashion in accordance with the odd‐even number allocation method, known as a randomized control trial." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Masking of participants and personnel was not reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Masking of outcome assessors was not reported. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Numbers excluded or lost to follow‐up were not explicitly reported. |
Selective reporting (reporting bias) | High risk | UDVA, which was proposed in the methods, was not reported in the results. |
Other bias | Unclear risk | It was unclear if participants were comparable at baseline. The authors reported: "While, mean Sim K astigmatism was 6.73 ± 1.98D in group 2 (range 4.3 D to 11.1 D). There was a significant difference between the two groups (P = 0.02)"; however, equivalent data in Table 2 showed a P value of 0.3. Lack of use of standard outcome measures (authors cite seminal papers that use standard measures) |