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

Morgado 2010.

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: Portugal
Setting: Hospital Pedro Hispano
Enrollment date: not reported
Baseline characteristics: not reported
Topical mydriatics
  • Number randomized: 30

  • Mean age, years (SD): 77.3 (NR)

  • Women n (%): 20 (66.6)

  • Race, n (%): not reported

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

  • Blood pressure, mean (SD): systolic 139.6 mmHg (16), diastolic 76.3 mmHg (9)

  • Alpha‐adrenergic agonists, number (%): 3 (10)

  • Pseudoexfoliation syndrome, number (%): 2 (6.6)

  • Diabetes mellitus, number (%): 7 (23.3)

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

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


Intracameral mydriatics
  • Number randomized: 30

  • Mean age, years (SD): 79.3 (NR)

  • Women n (%): 21 (70.0)

  • Race, n (%): n (%): not reported

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

  • Blood pressure, mean (SD): systolic 138.5 mmHg (13), diastolic 77.7 mmHg (12)

  • Alpha‐adrenergic agonists, number (%): 3 (10)

  • Pseudoexfoliation syndrome, number (%): 3 (10.0)

  • Diabetes mellitus, number (%): 9 (30.0)

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

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


Depot delivery systems
  • Number randomized: 30

  • Mean age, years (SD): 80.1 (NR)

  • Women n (%): 22 (73.3)

  • Race, n (%): not reported

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

  • Blood pressure, mean (SD): systolic 140.5 mmHg (18), diastolic 79.3 mmHg (11)

  • Alpha‐adrenergic agonists, number (%): 2 (6.6)

  • Pseudoexfoliation syndrome, number (%): 4 (13.3)

  • Diabetes mellitus, number (%): 8 (26.6)

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

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


Overall
  • Number randomized: 90

  • Mean age, years (SD): not reported

  • Women n (%): 63 (70.0)

  • Race, n (%): not reported

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

  • Blood pressure, mean (SD): not reported

  • Alpha‐adrenergic agonists, number (%): 8 (9)

  • Pseudoexfoliation syndrome, number (%): 9 (10)

  • Diabetes mellitus, number (%): 24 (27)

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

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


Inclusion criteria: "Eyes with senile cataract undergoing phacoemulsification surgery"
Exclusion criteria: "Eyes with iris posterior synechiae, prior eye surgery, and anterior segment malformation"
Pretreatment: "Demographic data, comorbidities, and eye parameters were considered homogenous between groups"
Interventions
  • Topical mydriatics: "1% tropicamide and 10% phenylephrine drop, applied 3 times with 5‐minute intervals, initiated 60 minutes before surgery"

  • Intracameral mydriatics: "Intracameral mydriasis with1% lidocaine (already performed in the anesthesia protocol) and 2.5% phenylephrine, administered into the anterior chamber, in a sequential manner (0.3 mL each drug)"

  • Depot delivery systems: "Mydriasert mydriasis, with the device being placed in the inferior conjunctival sac, at least 1 hour before surgery. The insert contains 0.28 mg tropicamide and 5.4 mg phenylephrine hydrochloride equivalent to 1 0.5% tropicamide and 10% phenylephrine drop"

Outcomes Primary: not reported
Secondary: not reported
Measured outcome: pupillary diameter at the beginning of procedure and at the end of procedure, intraoperative surgical time
Identification Author name: Gabriel Morgado
Institution: Department of Ophthalmology, Hospital Pedro Hispano, Porto, Portugal
Email: gabrielmorgado@iol.pt
Address: Rua do Monte 588 4405‐812 Vila Nova de Gaia Portugal
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 Method of random sequence generation not reported.
Allocation concealment (selection bias) Unclear risk Method of treatment allocation concealment not reported.
Masking of participants and personnel (performance bias) Unclear risk Masking of study participants and personnel not reported.
Masking of outcome assessment (detection bias) Unclear risk Masking of outcome assessors not reported.
Incomplete outcome data (attrition bias)
All outcomes Low risk Participant attrition not reported, but number randomized is the same as number analyzed, and there is no evidence of participants lost to follow‐up.
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.