Ozden 2011.
Study characteristics | ||
Methods |
Study design: randomised controlled trial Method of randomisation: randomisation list Blinding: participants ‐ no, doctor ‐ no, outcome assessors ‐ yes Power calculation: not mentioned Total number of participants: 21 Total number of procedures: 64 Treatment localisation: leg veins Number of exclusions post‐randomisation: none Number of withdrawals and reasons: 5 patients, 3 due to lack of time and 2 intolerability to pain |
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Participants |
Setting: outpatient site Country: Turkey Gender: women Age: mean 42.28 years (range 32 ‐ 60) Inclusion criteria: White women aged between 20 and 60 years with spider leg veins Exclusion criteria: prior history of DVT, previous treatment of leg veins, pregnancy, poor wound‐healing diseases, hypercoagulability and large varicose veins A series of 16 patients with size‐matched superficial telangiectases of the lower extremities were randomly assigned to receive 3 consecutive monthly treatments with the long‐pulsed 1064 nm Nd:YAG on 1 leg and 532‐nm KTP laser irradiation on the other |
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Interventions |
Treatment 1: Nd:YAG laser Treatment 2: KTP laser Participants received treatments with the Nd:YAG laser to vessels on 1 leg and with the KTP laser to the other leg, for up to 3 sessions every 4 weeks Duration of follow‐up: 1 month Use of compression: no compression stocking |
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Outcomes | The endpoint for laser sessions was determined to be when either visual elimination or darkening of the vessel was observed. Response to treatment was rated on a quartile system: 0 = no clearing; 1 = 1% ‐ 24% clearing; 2 = 25% ‐ 49% clearing; 3 = 50% ‐ 74% clearing; 4 = 75% ‐ 94% clearing; 5 = 95% ‐ 100% Side effects of treatment were also recorded at each treatment and follow‐up visit |
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Funding sources | No details provided | |
Declarations of interest | None declared | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was done by a person not involved in this study, who sent the patients on hand of a randomisation list" |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details given |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Results were judged visually by 2 experienced (1 independent) physicians on patient examination |
Incomplete outcome data (attrition bias) All outcomes | High risk | 5 participants: 3 lost to follow‐up and 2 intolerability to pain |
Selective reporting (reporting bias) | Unclear risk | No details given |
Other bias | Unclear risk | No details given |