Sir,
We thank Drs. Kaur and Sukhija for their interest in our article. They make several interesting and important points in their letter. They mention that difluprednate is a highly potent steroid that may cause intraocular pressure elevation. They also mention that they dose steroids more frequently than four times per day in infants and young children.
Our study was a multicenter randomized controlled trial comparing difluprednate 0.05% to prednisolone acetate 1% in children aged 0–3 years after cataract surgery.1 The U.S. FDA requested that the study be performed on children of this age.
We personally use four times per day dosing of topical prednisolone acetate in our practices after cataract surgery in infants and children. Over the last several years, we have each adopted a four times per day dosing regardless of age and increase the frequency only in unusual circumstances such as uveitic cataracts or some patients with trauma. This study provides support for that dosing choice since postoperative inflammation was adequately controlled in even our youngest enrollees. Infants less than 7 months of age were routinely left aphakic. Although it is true that some surgeons in the Infant Aphakia Treatment Study (IATS) used steroid drops more frequently than four times per day, the rate of inflammatory complications was not lower in those dosed more than four times per day.2 We can make no statement about the use of difluprednate more frequently than four times per day, but our study demonstrated good control of postoperative inflammation at that dosage and no increase in adverse events when compared with prednisolone acetate, the current standard.
The centers in our study were chosen, in part, because they were experienced and routinely successful at checking intraocular pressure in infants and small children. The Icare (Finland) rebound tonometer has become a popular device among pediatric cataract surgeons in the USA for measuring IOP in this age group without sedation pediatric cataract surgeons in the USA and it was used in this study.3 Both pre-surgery IOP and post-operative IOP readings were taken in a clinical area outside of the operating room. Our study IOP readings were not done under general anesthesia.
Since the IATS recommended that most infants under 7 months of age be left aphakic and treated with a contact lens, infants treated in this manner were enrolled and randomized in our study.4 Extended-wear silicone contact lenses or daily-wear rigid gas permeable contact lenses were used. With these materials (0% water content), we found no adverse events related to placing the drops on the eye while the contact lens was being worn. It is likely that the package insert advising against the instillation of topical difluprednate while wearing contact lens is for high water content contact lenses that are not available in the powers needed to correct aphakic infants.
Drug choice and dosing in infants and young children after cataract surgery will remain a personal choice of the surgeon. Our study provides evidence that difluprednate can be safely used at QID dosing in children aged 0–3 years.
References
Wilson ME, O'Halloran H, VanderVeen D, Roarty J, Plager DA, Markwardt K et al. Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients: a randomized safety and efficacy study. Eye (Lond) 2016; 30 (9): 1187–1194.
Lambert SR, Plager DA, Buckley EG, Wilson ME, DuBois L et alInfant Aphakia Treatment Study Group. The Infant Aphakia Treatment Study: further on intra- and postoperative complications in the intraocular lens group. J AAPOS. 2015; 19 (2): 101–103.
Lambert SR, Buffenn AN, Chiang MF, Coats DK, Melia M, Simpson JL et al. Rebound tonometry in children. Ophthalmology 2013; 12: e21–e27.
Lambert SR, Lynn MJ, Hartmann EE, DuBois L, Drews-Botsch CD et al(Writing Committee) The Infant Aphakia Treatment Study Group. Comparison of contact lens and intraocular lens correction of monocular aphakia during infancy: a randomized clinical trial of HOTV optotype acuity at age 4.5 years and clinical findings at age 5 years. JAMA Ophthalmol 2014; 132 (6): 676–684.
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Wilson, M., Lambert, S., Plager, D. et al. Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients: a randomized safety and efficacy study. Eye 31, 506–507 (2017). https://doi.org/10.1038/eye.2016.244
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DOI: https://doi.org/10.1038/eye.2016.244
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