Skip to main content
. 2020 Mar 18;2020(3):CD013559. doi: 10.1002/14651858.CD013559

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)
Participants Baseline characteristics
IPL group
  • Number of participants (number of eyes): 28 (28)

  • Sex (number of females/males): 20/8

  • Age (mean): 45 (SD 15) years


Sham (control) group
  • Number of participants (number of eyes): 28 (28)

  • Sex (number of females/males): 20/8

  • Age (mean): 44 (SD 15) years


Overall
  • Number of participants (number of eyes): 28 (56)

  • Sex (number of females/males): 20/8

  • Age (mean): 45 (SD 15) years


Inclusion criteria:
  • people with mild‐to‐moderate clinical signs of MGD;

  • aged ≥ 18 years;

  • good general health.


Exclusion criteria:
  • people with current and recent medication use for individuals whom light therapy was contraindicated;

  • clinical skin treatments within prior 2 months;

  • implants beneath treatment area;

  • tattoos, semi‐permanent makeup, pigmented lesions in treatment area;

  • contact lens wearing within 48 hours of commencing study or during study.


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
Interventions IPL group
  • Description: IPL treatment administered to the skin area immediately below the lower eyelid during 3 separate treatment sessions on days 1, 15 and 45 as per manufacturer recommendations. 4 pulses were applied as shown in Figure 1 of paper at a pulse intensity of 9–13 J/cm² and was inversely related to the individual skin phototype level as determined by the Fitzpatrick grading scale; IPL treatment was applied to 4 periocular zones inferior to the eye, while the eyes were protected by opaque goggles.

  • Duration: 45 days (with separate treatment sessions on days 1, 15 and 45).

  • Co‐interventions: none reported.


Sham (control) group
  • Description: sham IPL therapy; quote: "… 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."

  • Duration: 45 days (with separate treatment sessions on days 1, 15 and 45).

  • Co‐interventions: none reported.

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.
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
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.
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.