| 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. |