Craig 2015.
Methods |
Study design: randomised controlled trial Study grouping: intra‐person (between eye) comparative trial Exclusions after randomisation? (If Yes, provide relevant details from the paper): none (follow‐up data available for all 28 enrolled participants) Percentage of participant follow‐up (include details from all intervention groups): 100% Study duration (of intervention): 45 days Was a sample size calculation reported? (Yes/No): no (although a sample size calculation was available on the clinical trial registry entry) |
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Participants |
Baseline characteristics IPL group
Sham (control) group
Overall
Inclusion criteria:
Exclusion criteria:
Significant pretreatment baseline differences? No. Quote: "At baseline, there was no significant difference between the treated and control eyes in any outcome variable (p > 0.05 in all cases)." Severity of dry eye: mild‐to‐moderate MGD |
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Interventions |
IPL group
Sham (control) group
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Outcomes |
(As reported in the paper) Primary and secondary outcomes: not explicitly stated. Measurements included: best spectacle corrected visual acuity (logMAR), bulbar conjunctival injection graded on a VAS; NIBUT; fluorescein and lissamine green corneal and conjunctival staining; assignment of the tear LLG through tear film interferometry (Tearscope Plus, Keeler, UK), TMH, tear osmolality (TearLab Osmolarity System; TearLab, San Diego, California, US), TER (VapoMeter; Delfin, Kuopio, Finland), patient symptoms (measured with SPEED validated questionnaire and perceived severity of dry eye symptoms using a VAS anchored at each end with 'No symptoms' and 'Constant symptoms' as descriptors), at baseline (day 1), 15 and 45. |
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Identification |
Funding sources: supported by a summer studentship grant from the New Zealand Association of Optometrists (YHC) and consumables funding from France Medical. Declarations of interest: JP Craig, France Medical (F); YH Chen, none; PRK Turnbull, none Country: New Zealand Setting: eye clinic Comments: Publication status: published study Journal of publication: Investigative Ophthalmology and Visual Science Language: English Trial registration number: ACTRN12614000162617 Contacting study investigators: 1 review author (LED) contacted the trial corresponding author (A/Prof Craig) in September 2018 to clarify the method of allocation concealment. LED contacted Associate Professor Craig in January 2020 to clarify the quantitative data reported for the NIBUT outcome, as numeric values were inconsistent between the abstract and main text. The abstract values were confirmed to be correct. Date study conducted: not reported Corresponding author's name: Jennifer Craig Institution: University of Auckland, New Zealand Email: jp.craig@auckland.ac.nz Address: Department of Ophthalmology, University of Auckland, Private Bag 92019, Auckland 1142, New Zealand |
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Notes |
Adverse events: not reported Comments on statistical analysis: this study was an intra‐person (between eye) comparative trial. Although it appears from the text in the paper that a paired analysis was performed (to account for the correlation between eyes), the results presented in the paper appear not to be from a paired analysis. This represents a statistical analysis error, which limits our confidence in the reported inter‐eye differences. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "One eye was selected for treatment according to a computer‐generated randomization program, with the other eye assigned to serve as a mock‐treated control." Judgement comment: computer‐generated randomisation list. |
Allocation concealment (selection bias) | Low risk | Judgement comment: not reported how allocation was administered. Contacted trial author (Craig) and clarified that the allocation was concealed. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Double masked"; "participant masking was employed with a white‐blocking filter applied over the tip of the IPL probe during application to the nontreated eye only." Judgement comment: clearly stated that participants were masked; there were no associated personnel. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The researcher collecting the clinical data was masked as to which eye was treated, and participant masking was employed with a white‐blocking filter applied over the tip of the IPL probe during application to the non‐treated eye only." Judgement comment: clearly stated that the outcome assessor was masked. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "The full cohort of 28 enrolled participants completed measurements across all three appointments and were included in the analysis." Judgement comment: complete follow‐up reported. |
Selective reporting (reporting bias) | High risk | Judgement comment: all outcomes in the clinical trial registry (ACTRN12614000162617) were reported. However, selective outcome reporting was suspected as the following additional outcomes (not listed in the clinical trial registry entry) were also reported in the methods section of the paper: TER, TMH, tear osmolarity, SPEED symptom questionnaire, and lissamine green corneal and conjunctival staining. In the results, findings for meibography, and fluorescein and lissamine green staining were also not provided in the paper. |
Other bias | Low risk | Judgement comment: no other apparent significant sources of bias. |