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

Hargitai 2013.

Study characteristics
Methods Study design: randomized controlled trial, parallel group
Loss to follow‐up: not reported
Intention‐to‐treat: all participants were analyzed in the groups to which they had been assigned
Sample size estimation: with 25 participants in each of 2 groups, a 0.8‐millimeter difference between groups will be recognized by an unpaired t‐test with 80% probability assuming a within‐group standard deviation of approximately 1 mm
Participants Country: Denmark
Setting: hospital
Enrollment year: 2012
Baseline characteristics:
Topical mydriatics
  • Number randomized: 28

  • Mean age, years (SD): 76.64 (6.85)

  • Women, n (%): 0 (0)

  • Race, n (%): not reported

  • Preoperative pupillary diameter, mean, mm (SD): 7.30 (1.55)

  • Blood pressure, mean (SD): not reported

  • Alpha‐adrenergic agonists, n (%): 28

  • Pseudoexfoliation syndrome, n (%): 0

  • Diabetes mellitus, n (%): 10

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

  • Pre‐ and intraoperative NSAIDs at baseline, n (%): 28


Depot delivery systems
  • Number randomized: 30

  • Mean age, years (SD): 78.6 (10.35)

  • Women, n (%): 0 (0)

  • Race, n (%): not reported

  • Preoperative pupillary diameter, mean, mm (SD): 7.52 (1.21)

  • Blood pressure, mean (SD): not reported

  • Alpha‐adrenergic agonists, n (%): 30

  • Pseudoexfoliation syndrome, n (%): 0

  • Diabetes mellitus, n (%): 10

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

  • Pre‐ and intraoperative NSAIDs at baseline, n (%): 30


Overall
  • Number randomized: 58

  • Mean age, years (SD): 78.6 (10.35)

  • Women, n (%): 0 (0)

  • Race, n (%): not reported

  • Preoperative pupillary diameter, mean, mm (SD): 7.52 (1.21)

  • Blood pressure, mean (SD): not reported

  • Alpha‐adrenergic agonists, n (%): 58

  • Pseudoexfoliation syndrome, n (%): 0

  • Diabetes mellitus, n (%): 20

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

  • Pre‐ and intraoperative NSAIDs at baseline, n (%): 58


Inclusion criteria: male patients taking tamsulosin due to benign prostatic hypertrophy, attending elective cataract surgery
Exclusion criteria: previous ocular surgery, posterior synechiae, and the use of drops other than artificial tears
Pretreatment: 1‐way ANOVA showed no significant difference between the groups in terms of age
Interventions Intervention group: oxybuprocaine 0.4%, cocaine 4%, tropicamide 1%, phenylephrine 10%, diclofenac 0.1%, and chloramphenicol 0.5% eyedrops were used preoperatively. Cellulose wicks were prepared and submerged in a mix of the above solutions with 1:1:1:1:1:1 ratio.
Comparator: oxybuprocaine 0.4%, cocaine 4%, tropicamide 1%, phenylephrine 10%, diclofenac 0.1%, and chloramphenicol 0.5% eyedrops were used preoperatively. Drops were supplied 3 times with 10‐minute intervals.
Outcomes Primary outcome: pupil diameter (mm), after nucleus delivery, and before IOL implantation
Secondary outcome: not reported
Measured outcomes: total intraoperative miosis (mm), mean (SD)
Identification Author name: János Hargitai
Institution: Thy‐Mors Hospital
Email: janos.hargitai@rn.dk
Address: Department of Ophthalmology, Thy‐Mors Hospital, Højtoftevej 2, Thisted7700, Denmark
Clinical Trials Registration Number: not reported
Notes Comments: 30 participants were dilated using the mydriatics cocktail‐soaked sponge (group 1), and 30 participants were dilated using conventional repeated eyedrops regimen (group 2); there was an additional "control" (non‐randomized) group of 31 participants not receiving any α1 adrenergic receptor antagonist medication who also were dilated with mydriatic‐cocktail soaked sponge. Minor (3/30, 2/28, and 1/31 respectively) and major (1/30, 0/28, and 0/31 respectively) complication rate was similar among all groups.
Sponsorship source: not reported
Conflict of interest: the authors declare that they have no competing interests
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Authors did not describe how the random sequence was generated.
Allocation concealment (selection bias) Low risk The study group was subdivided randomly into 2 equal‐sized groups (n = 30), using sealed envelope method.
Masking of participants and personnel (performance bias) High risk Masking of participants not described; surgeons were masked.
Masking of outcome assessment (detection bias) Unclear risk Identity and masking of outcome assessors not reported.
Incomplete outcome data (attrition bias)
All outcomes Low risk Data reported for all randomized participants, except for 2 who were excluded because they could not lie flat.
Selective reporting (reporting bias) Low risk Outcomes stated in trial registry same as reported in paper.