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

Li 2006.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: parallel group
Loss to follow‐up: not reported
Intention‐to‐treat: participants were analyzed in the groups to which they had been assigned
Sample size estimation: not reported
Participants Country: China
Setting: ophthalmology center of a teaching hospital
Enrollment date: not reported
Baseline characteristics
Topical mydriatics
  • Number randomized: 46

  • Mean age, years (SD): 68.8 (NR)

  • Women n (%): 32 (57.1)

  • Race, n (%): Asian, n (%): 46 (100)

  • 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 (%): 0

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

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


Intracameral mydriatics
  • Number randomized: 34

  • Mean age, years (SD): 69 (NR)

  • Women n (%): 24 (42.9)

  • Race, n (%): Asian, n (%): 34 (100)

  • 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 (%): 0

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

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


Overall
  • Number randomized: 80

  • Mean age, years (SD): not reported

  • Women n (%): 56 (70)

  • Race, n (%): Asian, n (%): 34 (100)

  • 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 (%): 0

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

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


("NOTE: Some values published as "SDs" may be "SEs".)
Inclusion criteria: continuous cases of phacoemulsification and intraocular lens implantation were performed at the Zhongshan Ophthalmic Center of Sun Yat‐sen University from January 2004 to June 2004. The inclusion criteria included: (1) medium nuclear hardness (II) ~ III grade cataract patients, because of the high risk of hard or hard nuclear phacoemulsification itself, affecting the trial; (2) no glaucoma, uveitis, fundus lesions, and other eye abnormalities; (3) no surgery complications such as uveitis and fulminant choroidal hemorrhage
Exclusion criteria: (1) patients with eye abnormalities, such as glaucoma, uveitis, fundus lesion, etc.; (2) patients with complications of surgery origin, such as uveitis, choroidal expulsive hemorrhage
Pretreatment: not reported
Interventions
  • Topical mydriatics: compound tropicamide eyedrops

  • Intracameral mydriatics: 1% hydrochloride lidocaine

Outcomes Primary: not reported
Secondary: not reported
Measured outcome: pupillary size at time of capsulorhexis, at the beginning of procedure
Identification Author name: Xiumei Li
Institution: Ophthalmology center of Sun Yat‐sen University
Email: zhenpinz@hotmail.com
Address: Ophthalmology center of Sun Yat‐sen University, Guangzhou, China 510060
Clinical Trials Registration Number: not reported
Notes Sponsorship source: not reported
Conflict of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Authors mentioned random number generation, but it is unclear how this was generated.
Allocation concealment (selection bias) Unclear risk Method of treatment allocation concealment before assignment not reported.
Masking of participants and personnel (performance bias) Unclear risk Masking of participants and study personnel not reported.
Masking of outcome assessment (detection bias) Unclear risk Masking of outcome assessors not reported.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Participant attrition not reported.
Selective reporting (reporting bias) Unclear risk No trial registration; however, while outcomes specified in the methods section were reported in the results section, selective outcome reporting may still exist.