Prospective Multicenter Evaluation of Cataract Surgery in Patients Taking Tamsulosin (Flomax)

doi:10.1016/j.ophtha.2007.01.011

Ophthalmology

Volume 114, Issue 5, May 2007, Pages 957-964

Presented at: American Academy of Ophthalmology Annual Meeting, November 2006, Las Vegas, Nevada.

https://doi.org/10.1016/j.ophtha.2007.01.011 Get rights and content

Purpose

Intraoperative floppy iris syndrome (IFIS) caused by systemic α-blockers has been associated with an increased risk of cataract surgical complications when the surgeon was unaware of the medication history and did not anticipate its occurrence. This study was undertaken to evaluate the surgical outcomes and rate of complications when the ophthalmologist knew the patient was taking tamsulosin (Flomax, Boehringer-Ingelheim Pharmaceuticals, Ridgefield, CT) and used 1 of several strategies to manage IFIS.

Design

Prospective multicenter nonrandomized observational series.

Participants

A total of 167 consecutive eyes in 135 patients taking tamsulosin and undergoing cataract surgery.

Methods

Phacoemulsification was performed in conjunction with at least 1 of 4 different IFIS management strategies, namely, topical atropine preoperatively, iris retractors, pupil expansion ring, or use of viscoadaptive ophthalmic viscosurgical device with reduced fluidic parameters.

Main Outcome Measures

Severity of IFIS, incidence of operative or postoperative complications, and final visual acuity.

Results

The IFIS severity was rated as mild in 17%, moderate in 30%, and severe in 43% of the study eyes. No IFIS was noted in 10% of the eyes. The rate of posterior capsule rupture and vitreous loss was 0.6% (1/167; 95% confidence interval, 0%–1.8%). Ninety-five percent of eyes achieved a best-corrected visual acuity of at least 20/40.

Conclusion

When experienced surgeons could anticipate IFIS and employ compensatory surgical techniques, the complication rate from cataract surgery was low and the visual outcomes were excellent in eyes of patients with a history of tamsulosin use.

Section snippets

Patients and Methods

All eligible cataract patients taking tamsulosin were consecutively enrolled at 1 of 10 study sites in the United States. All of the investigators were highly experienced cataract surgeons; their names and practice locations are listed under Tamsulosin Study Group in the Appendix. Institutional review board approval was obtained, as was written informed patient consent. Male or female patients undergoing cataract surgery who were taking tamsulosin were eligible. Patients were excluded if there

Patient Characteristics

Between March and September 2005, 167 consecutive eyes in 135 patients taking tamsulosin were enrolled at the 10 study sites. All of the patients were male, and 15% of the surgeries were in diabetic patients. Pseudoexfoliation was present in 6% of the eyes. The iris color was blue in 49% of the eyes, brown in 36% of the eyes, and blue-green in 15% of the eyes. Preoperatively, the nuclear density was graded as being 1 to 2+ in 65% and 3 to 4+ in 35% of the eyes. Topical 1% cyclopentylate was

Discussion

Intraoperative floppy iris syndrome is most commonly caused by systemic α₁-adrenergic antagonists, such as tamsulosin.1, 2, 3, 4, 5 In our study of tamsulosin patients presenting for cataract surgery, IFIS was diagnosed in 90% of the eyes enrolled. Among currently prescribed α₁-antagonists, tamsulosin is the only drug that is selective for the α_1A-receptor subtype.18, 19 This is the predominant α₁-receptor subtype present in both the prostate and iris dilator smooth muscle.19, 20, 21 Because of

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Cited by (157)

Impact of intraoperative floppy IRIS syndrome in cataract surgery by phacoemulsification: Analysis of 622 cases
2023, Archivos de la Sociedad Espanola de Oftalmologia
Los síndromes de pupila estrecha, incluido el síndrome de iris flácido intraoperatorio (IFIS), aumentan el riesgo de complicaciones durante la cirugía de cataratas si no se realiza una correcta planificación quirúrgica. La tamsulosina se asocia a un incremento muy significativo del riesgo de IFIS, debido a la inactivación prolongada de los receptores alfa-1 adrenérgicos en la fibra muscular lisa del iris.
Estudio prospectivo observacional unicéntrico, llevado a cabo en el Hospital de l’Esperança - Parc de Salut Mar.
Se incluyeron 622 ojos de 502 pacientes, de los cuales 337 (62%) eran mujeres. La media de edad de la muestra era de 74,8 años. Se observaron 61 casos de IFIS (11%), de los cuales 13 recibían tratamiento con tamsulosina y uno con doxazosina. Se observaron 23 casos de IFIS en pacientes mujeres. La ratio mujer:hombre fue de aproximadamente 1:3. Se observaron 19 casos (3%) de IFIS severo, de los cuales 6 recibían tratamiento con alfa-antagonistas, sin correlación estadísticamente significativa.
La media del tiempo quirúrgico fue de 13,80 min (desviación estándar [DE]: 4,01 min) en pacientes sin IFIS y de 16,93 min (DE: 4,32 min) en pacientes con IFIS. La relación entre la duración del procedimiento quirúrgico en minutos y la presencia de IFIS fue estadísticamente significativa, aplicando un test t-Student «a dos colas» o bilateral con un p valor de 0,01.
Independientemente del grado de severidad, el diagnóstico de IFIS alarga el tiempo quirúrgico en cirugía de cataratas. Esto supone otra evidencia más que apoya la utilización de tratamientos antagonistas adrenérgicos menos alfa-1 selectivos que la tamsulosina o la realización de la cirugía de cataratas antes de iniciar dichos tratamientos.
Small pupil syndromes, including intraoperative-floppy iris syndrome (IFIS), increase the risk of complications during cataract surgery if proper surgical planning is not performed. Tamsulosin is associated with a very significant increase in the risk of IFIS, due to the prolonged inactivation of alpha-1 adrenergic receptors in the smooth muscle fiber of the iris.
Single-center prospective observational study, carried out at the Hospital de l’Esperança – Parc de Salut Mar.
Six hundred and twenty-two eyes of 502 patients were included, of which 337 (62%) were women. The mean age of the sample is 74.8 years. Sixty-one cases of IFIS (11%) were observed, of which 13 received treatment with Tamsulosin and 1 with Doxazosin. Twenty-three cases of IFIS were observed in female patients. The female:male ratio was approximately 1:3. Nineteen cases (3%) of severe IFIS were observed, of which 6 received treatment with alpha-antagonists, with no statistically significant correlation.
The mean surgical time was 13.80 min (standard deviation – SD: 4.01 min) in patients without IFIS and 16.93 min (SD: 4.32 min) in patients with IFIS. The relationship between the duration of the surgical procedure in minutes and the presence of IFIS was statistically significant, applying a ‘two-tailed’ or bilateral t-Student test with a p value of 0.01.
Regardless of the degree of severity, the diagnosis of IFIS lengthens the surgical time in cataract surgery. This represents yet another piece of evidence that supports the use of less selective alpha-1 adrenergic antagonist treatments than tamsulosin or the performance of cataract surgery before starting these treatments.
A Case of Foldable Artificial Iris Implantation for Treatment of Postcataract Surgery Aniridia
2023, Case Reports in Ophthalmology
Iris Complications and Management in Cataract Surgery
2023, Cataract and Lens Surgery
The impact of oral and systemic medications on the eye
2023, Community Eye Health Journal
Floppy iris syndrome associated with specific medication intake: A narrative review
2023, Biomedical Papers
Factors predisposing to intraoperative floppy-iris syndrome: An up-to-date meta-analysis
2022, Journal of Cataract and Refractive Surgery

View all citing articles on Scopus

: Manuscript no. 2006-1066.

: The authors have no direct financial interest in any material or method mentioned. Drs Chang, Osher, and Koch are consultants for Advanced Medical Optics and Alcon.

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Original ArticleProspective Multicenter Evaluation of Cataract Surgery in Patients Taking Tamsulosin (Flomax)

Purpose

Design

Participants

Methods

Main Outcome Measures

Results

Conclusion

Section snippets

Patients and Methods

Patient Characteristics

Discussion

J Cataract Refract Surg

J Cataract Refract Surg

Ophthalmology

J Cataract Refract Surg

Ophthalmology

Surv Ophthalmol

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Urol

Exp Eye Res

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

Ophthalmology

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

Original Article
Prospective Multicenter Evaluation of Cataract Surgery in Patients Taking Tamsulosin (Flomax)