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Comparison · NCT01640171-sae

Topical Anesthesia vs Subconjunctival Anesthesia: serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Topical Anesthesia vs Subconjunctival Anesthesia: serious adverse events. Trial comparisons, record NCT01640171-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01640171-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.0631wilson
Risk in group 2000.0631wilson
Risk difference, group 1 minus group 20-0.06310.0631newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Topical Anesthesia
Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion
057EG000
Group 2Subconjunctival Anesthesia
Eye receiving topical gel and subconjunctival lidocaine~Xylocaine 2% Injectable Anesthetic: xylocaine 2% injection 0.1 cc~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion
057EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Anesthesia Preference for Intravitreal Injection: Topical or Subconjunctival
NCT number
NCT01640171
Phases
NA
Conditions
Age-related Macular Degeneration, Central Retinal Vein Occlusion, Diabetic Macular Edema
Interventions
Xylocaine 2% Injectable Anesthetic, Proparacaine Hydrochloride 0.5% Drop, Tetravisc 0.5% Gel, Acuvail, Intra-vitreal Anti-VEGF Drug
Lead sponsor
Retina Vitreous Associates of Florida
Results first posted
2014-04-21

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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