McCormick 2006.
| Study characteristics | ||
| Methods |
Study design: randomized controlled trial Study grouping: parallel group Loss to follow‐up: no losses to follow‐up; all 56 randomized participants were included in the analysis Intention‐to‐treat: participants were analyzed in the groups to which they had been assigned Sample size estimation: a power calculation was carried out prior to commencing the study to determine the appropriate sample size. A difference in horizontal pupil diameter of 1 mm was felt to be clinically significant. In order to estimate the standard deviation of pupil diameter, measurements were taken from a separate cohort of 20 preoperative cataract patients. |
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| Participants |
Country: United Kingdom Setting: hospital Enrollment date: not reported Baseline characteristics Topical mydriatics
Depot delivery systems
Overall
Inclusion criteria: "Patients due to attend for routine local anaesthetic phacoemulsification cataract surgery in our unit under a single consultant during a 2‐month period (13 May to 12 July 2004) were included" Exclusion criteria: "Patients with pseudoexfoliation syndrome and ocular cicatricial pemphigoid whose fornix precluded the placement of a pledget" Pretreatment: no differences in baseline characteristics were reported |
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| Interventions |
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| Outcomes |
Primary: horizontal pupil diameter measured in millimetres immediately prior to surgery Secondary: tolerability of the pledget, cornea abrasion |
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| Identification |
Author name: Dr Austin McCormick Institution: Department of Ophthalmology, Faculty of Medical and Health Sciences, The University of Auckland Email: amccormick@slingshot.co.nz Address: Department of Ophthalmology, Faculty of Medical and Health Sciences, The University of Auckland, Private Bag 92019, Auckland, New Zealand Clinical Trials Registration Number: ISRCTN63768137 |
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| Notes |
Comment: in the topical mydriatics, the analysis of participant stinging gave a range of 0 to 5, median of 2 (95% CI: 0 to 3) and mean of 1.9 (95% CI 1.17 to 2.63). In the depot delivery, the range was 0 to 4, median of 1 (95% CI 0 to 2) and mean of 1.52 (95% CI 0.95 to 2.09). Sponsorship source: not reported Conflict of interest: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | See below. Number of cards, whether draws were with or without replacement, and other details not reported. |
| Allocation concealment (selection bias) | Low risk | On the day of surgery, small pieces of card were placed in a bag with the words ‘trial’ or ‘control.’ Once the participant had consented to be part of the study, a card was picked from the bag by a nurse not involved in the study. |
| Masking of participants and personnel (performance bias) | High risk | It was not possible to conceal the arm of the trial from the participant due to the nature of the intervention. |
| Masking of outcome assessment (detection bias) | Low risk | Outcome assessors were masked. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no losses to follow‐up, and all 56 randomized participants were included in the analysis. |
| Selective reporting (reporting bias) | Low risk | Outcomes specified in trial registry as well as the methods section of the paper were reported in the results. |