Murphy 2018.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: parallel group; multi‐arm Power/Sample size calculation: NR |
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Participants |
Baseline characteristics Group A: Dr. Organic TTFW Number of participants: 22 Age – mean: 49.6 (SD 17.1) years Women %: NR Demodex count per 4 eyelashes – mean: 4.9 (range: 0–21) OSDI score – mean: 27.4 (SD 16.7) Visual acuity: NR Number of cylindrical dandruff: NR Group B: OcuSoft Lid Scrub Plus Number of participants: 24 Age – mean: 49.6 (SD 16.9) years Women %: NR Demodex count per 4 eyelashes – mean: 3.8 (range: 0–11) OSDI score – mean: 28.6 (SD 23.6) Visual acuity: NR Number of cylindrical dandruff: NR Group C: BlephEx microblepharoexfoliation device Number of participants: 23 Age – mean: 49.86 (SD 19.7) years Women %: NR Demodex count per 4 eyelashes – mean: 6.5 (range: 1–25) OSDI score – mean: 30.1 (SD 19.8) Visual acuity: NR Number of cylindrical dandruff: NR Overall Number of participants: NR Age: NR Women %: NR Demodex count per 4 eyelashes: NR OSDI score: NR Visual acuity: 1.08 (SD 0.26) Number of cylindrical dandruff: NR Inclusion criteria: aged > 18 years Exclusion criteria: ocular surgery in the past 6 months, or undergoing current ophthalmic treatment Pretreatment: individual groups seemed to be balanced; however, their unorthodox control groups were small and younger than the people within their respective groups. |
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Interventions |
Intervention characteristics Group A: Dr. Organic TTFW
Group B: OcuSoft Lid Scrub Plus
Group C: BlephEx microblepharoexfoliation device
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Outcomes | Mean severity of symptoms score (via modified version of the OSDI dry eye questionnaire); habitual visual acuity (LogMAR); slit lamp exam to assess and grade presence of cylindrical dandruff; and assessment for presence of Demodex. | |
Identification |
Sponsorship source: materials used in study supplied by Scope Ophthalmics and Dr. Organic Ltd. Country: Ireland Setting: Dublin Institute of Technology Comments: none Authors name: Orla Murphy Institution: Dublin Institute of Technology Address: NR Clinical trial registry/registration number: NR |
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Notes | Each of the three arms also includes "control" participants who did not have Demodex follicurlorum | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Judgment comment: participants were asked to choose a number from a list. Each number corresponded to a treatment. |
Allocation concealment (selection bias) | Unclear risk | Quote: "Each subject chose a number from the list, which corresponded to the treatment assigned to the subject." Judgment comment: information not provided. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "The examiner was blind to the treatment throughout all stages of the study for group A and group B. The examiner performed the BlephEx™ treatment on subjects from group C and was therefore not blind to the treatment in this group." Judgment comment: examiner knew who was in 1 of the groups, and the participants knew which group they were in. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "The examiner performed the BlephEx™ treatment on subjects from group C and was therefore not blind to the treatment in this group." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgment comment: there is sufficient explanation provided for all analysis. No missing data reported |
Selective reporting (reporting bias) | Unclear risk | Judgment comment: no prepublished protocol listed, so we could not determine if there was selective reporting. |