Drugs Associated With Floppy Iris Syndrome: A Real-World Population-Based Study
Bibliographic record
Abstract
Purpose Intraoperative floppy iris syndrome (IFIS) is associated with an increased rate of severe intraoperative complications and greater visual morbidity during cataract surgery, particularly in females. To date, no postmarketing pharmacovigilance study has comprehensively examined all FDA-approved drugs for their association with IFIS development or explored potential sex differences. Understanding the risk factors for IFIS allows cataract surgeons to better stratify surgical risks and implement appropriate preoperative and intraoperative measures to ensure adequate management in high-risk patients. Design Retrospective pharmacovigilance clinical cohort study. Methods This population-based, observational study analyzed IFIS cases reported to the Food and Drug Administration Adverse Event Reporting System from October 2003 to March 2024 using OpenVigil 2.1. Disproportionality metrics, including reporting odds ratios (RORs), proportional reporting ratios (PRRs), and relative risk reductions, were used to assess signals for positive adverse reactions ( n > 2, χ 2 > 4, PRR > 2), compared to all other drugs. Subgroup analyses were also conducted by sex. Results Of 12,345,128 adverse event reports, 649 (0.0053%) involved IFIS. The majority of cases were reported by healthcare professionals (75.75%, n = 203), followed by consumers (12.69%, n = 34) and unknown sources (11.57%, n = 31). Drugs with the highest disproportionality for IFIS included imipramine (ROR = 251.66, 95% confidence interval [CI] = 157.53-402.02), tamsulosin (ROR = 171.44, 95% CI=143.12-205.36), and chlorpromazine (ROR = 91.30, 95% CI=49.91-167.03) (all P < .0001, IC 025 > 0). Over-reported drug classes included α1-blockers, tricyclic antidepressants, atypical antipsychotics, carbonic anhydrase inhibitors, corticosteroids, 5α-reductase inhibitors, β-blockers, prostaglandin analogs, and β2-agonists. Among females, brinzolamide (ROR = 409.63, 95% CI=196.78-852.73) and salbutamol (ROR = 67.12, 95% CI=28.37-158.80) were disproportionately associated with IFIS (both P < .0001, IC 025 > 0), whereas these associations were not observed in males. Conclusions This analysis of over 20,000 drugs and 12 million reports highlights that, in addition to α1-blockers and atypical antipsychotics, tricyclic antidepressants are among the key agents most disproportionately associated with IFIS, with notable sex differences. These findings are crucial for informing perioperative counseling and surgical planning for cataract surgery.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".