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. 2021 May 27;2021(5):CD012830. doi: 10.1002/14651858.CD012830.pub2

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.
Participants Country: United Kingdom
Setting: hospital
Enrollment date: not reported
Baseline characteristics
Topical mydriatics
  • Number randomized: 31

  • Mean age, years (SD): 77 (NR)

  • Women n (%): 21 (67.7)

  • Race, n (%): not reported

  • Preoperative pupillary diameter, mean, mm (SD): not reported

  • Blood pressure, mean (SD): not reported

  • Alpha‐adrenergic agonists, number (%): not reported

  • Pseudoexfoliation syndrome, number (%): 0

  • Diabetes mellitus, number (%): not reported

  • Pre‐existing cardiac conditions, number (%): not reported

  • Pre‐ and intraoperative NSAIDs at baseline, number (%): not reported


Depot delivery systems
  • Number randomized: 25

  • Mean age, years (SD): 70 (NR)

  • Women n (%): 13 (52)

  • Race, n (%): not reported

  • Preoperative pupillary diameter, mean, mm (SD): not reported

  • Blood pressure, mean (SD): not reported

  • Alpha‐adrenergic agonists, number (%): not reported

  • Pseudoexfoliation syndrome, number (%): 0

  • Diabetes mellitus, number (%): not reported

  • Pre‐existing cardiac conditions, number (%): not reported

  • Pre‐ and intraoperative NSAIDs at baseline, number (%): not reported


Overall
  • Number randomized: 56

  • Mean age, years (SD): 70 (NR)

  • Women n (%): 34 (60.7)

  • Race, n (%): not reported

  • Preoperative pupillary diameter, mean, mm (SD): not reported

  • Blood pressure, mean (SD): not reported

  • Alpha‐adrenergic agonists, number (%): not reported

  • Pseudoexfoliation syndrome, number (%): 0

  • Diabetes mellitus, number (%): not reported

  • Pre‐existing cardiac conditions, number (%): not reported

  • Pre‐ and intraoperative NSAIDs at baseline, number (%): not reported


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
Interventions
  • Topical mydriatics: "2 drops each of Tropicamide 1%, phenylephrine 2.5% and atropine 1% administered to the lower conjunctival fornix spaced 3 min apart"

  • Depot delivery systems: 3‐millimeter pledget trimmed, soaked in tropicamide 1%, phenylephrine 2.5%, and atropine 1%, and placed in the inferior fornix for 20 min

Outcomes Primary: horizontal pupil diameter measured in millimetres immediately prior to surgery
Secondary: tolerability of the pledget, cornea abrasion
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
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
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.