Arita 2019.
Methods |
Study design: randomised controlled trial Study grouping: parallel group, where both eyes from an individual participant were considered as independent samples for the statistical analysis (representing a unit of analysis issue). Exclusions after randomisation (if Yes, provide relevant details from the paper): 3 participants in the MGX (control) group subsequently withdrew from the study because of pain during the procedure. Percentage of participant follow‐up (include details for all intervention groups): MGX group: 20/23 participants (87% follow‐up); IPL‐MGX group: 22/22 participants (100% follow‐up) Study duration (of intervention): quote: "Each patient underwent a series of eight treatment sessions at 3‐week intervals. After the eight treatment sessions, each patient underwent three follow‐up examinations over the course of 11 weeks." Was a sample size calculation reported (Yes/No): yes |
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Participants |
Baseline characteristics IPL + MGX group
MGX only group
Overall
Inclusion criteria:
Exclusion criteria: none reported. Significant pretreatment baseline differences? No significant inter‐group differences at baseline. Severity of dry eye: reported as "refractory MGD;" dry eye severity not explicitly reported. |
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Interventions |
IPL + MGX group
MGX only group
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Outcomes |
(As reported in the paper) Primary and secondary outcomes: not explicitly stated Measurements included:
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Identification |
Funding sources: no specific grant from funding agencies in the public, commercial or not‐for‐profit sectors. Declarations of interest: RA holds patents on the non‐contact meibography technique described in this manuscript (Japanese patent registration no. 5281846; US patent publication no. 2011–0273550A1; European patent publication no. 2189108A1), is a consultant for Kowa Company (Aichi, Japan) and Lumenis Japan (Tokyo, Japan), and has received financial support from TearScience (Morrisville, North Carolina, US). The other authors declared no potential conflict of interest. Country: Japan Setting: Itoh Clinic Comments: Publication status: published study Journal of publication: Ocular Surface Language: English Trial registration number: UMIN000022747. Contacting study investigators: 1 review author (LED) contacted the corresponding author August 2019 to confirm that data presented in the paper represented the inclusion of data from both eyes, as independent samples, without adjustment for within‐person correlation. LED contacted the corresponding author in November 2019 to obtain further information about the random sequence generation and allocation concealment methods, which informed the risk of bias assessment. LED asked for relevant information relating to the within‐person correlation. However, the authors advised that they would not be able to provide this information or the data to facilitate its calculation. Date study conducted: May 2016 to August 2017 Corresponding author's name: Reiko Arita Institution: Itoh Clinic, Saitama, Japan Email: ritoh@za2.so‐net.ne.jp Address: Department of Ophthalmology, Itoh Clinic, 26‐11 Minami‐Nakano, Minumaku, Saitama, Saitama, 337‐0042, Japan |
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Notes | Adverse events: not explicitly reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Refractory MGD patients were randomly assigned to receive either IPL with MGX (IPL‐MGX) or MGX alone as a control." Judgement comment: email correspondence with Dr Arita (5 November 2019) confirmed that the randomisation code was generated using a computer‐generated list. |
Allocation concealment (selection bias) | Low risk | Quote: "Refractory MGD patients were randomly assigned to receive either IPL with MGX (IPL‐MGX) or MGX alone as a control." Judgement comment: email correspondence with Dr Arita (5 November 2019) confirmed that the allocation was concealed by means of a computer‐based system for participant randomisation. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Judgement comment: open label or no information on masking. We assume that in the absence of reporting, participants and personnel were not masked. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Judgement comment: open label or no information on masking. We assume that in the absence of reporting, outcome assessors were not masked. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Ninety eyes of 45 patients were enrolled in the study. Three patients in the MGX (control) group subsequently withdrew from the study because of pain during the procedure, leaving a total of 20 patients in the MGX group and 22 patients in the IPL‐MGX group." Judgement comment: missing data < 20% (i.e. > 80% participant follow‐up) and relatively equal follow‐up in both groups and no obvious reason why loss to follow‐up should be related to outcome. |
Selective reporting (reporting bias) | High risk | Judgement comment: mismatches between clinical trial registry entry for outcome measures, and how data were reported in the paper. For example, corneal and conjunctival fluorescein staining score and NIBUT are reported in the paper but not listed in the clinical trial registry. The primary outcome measure listed on the clinical trial registry (meibum grade quality) is reported in the paper, but not specified as the primary outcome measure. |
Other bias | Low risk | Judgement comment: no other apparent sources of bias. |