Anterior Stromal Puncture vs. Annular Keratotomy in the Treatment of Painful Bullous Keratopathy: Randomized Clinical Trial

Purpose: Determine if anterior stromal puncture (ASP) has a more effective decrease in symptomatology (pain, photophobia, and foreign body sensation) than annular keratotomy (AK) in patients with painful bullous keratopathy (PBK) and poor visual prognosis. Methods: Patients with PBK, refractory to combined medical treatment and poor visual prognosis were randomly assigned to one of two surgical procedures. Symptomatology, central corneal thickness (CCT), visual acuity (VA), and best corrected (BCVA) were evaluated with a 12-month follow up. Results: From 78 patients with PBK, 13 met inclusion criteria; ASP was performed to 7 and AK to 6 of them. There was improvement in the magnitude of symptoms in both groups; however, there was no difference when groups were compared. CCT showed in the 7-month follow-up a significant reduction of 10.4% in the ASP group compared with a 9.6% increase in the AQ group (p=0.05). Twelve-month-follow up CCT presented a non-significant reduction of 9.3% in the ASP group compared with a 3.3% increase in the AQ group. VA and BCVA in both groups were not modified. None of the groups presented complications related to the surgical procedures. Conclusion: In this clinical trial, we documented that ASP and AQ produce a similar improvement in the symptomatology of patients with PBK refractory to combined medical treatment and poor VA potential. The ASP group additionally presented a significant decrease in CCT at 7 months of follow up, which looses statistical significance at 12 months of follow up, but maintains a clinical reduction of 9.3%. A longer follow-up period would be required to evaluate if this CCT reduction is able to modify the frequency Maria de los Angeles Ramos-Cadena, MD1,2, Gustavo Aguilar-Montes, MD1, Margarita Torres-Tamayo, MD3 Corresponding author: Maria de los Angeles Ramos Cadena, MD Pirules 144, Jardines del Pedregal, Delegación Álvaro Obregón, C.P. 01900, Mexico City, Mexico. Telephone: 5255 5568 22 94 Cell phone: 1 9172579091 Fax: 5255 5935 1974 Email: [email protected] Funding: None Proprietary/financial interest: None 1 Hospital General Dr. Manuel Gea González, Department of Ophthalmology, Mexico City, Mexico. 2 Asociación Para Evitar la Ceguera en México, Glaucoma Service, Mexico City, Mexico. 3 Instituto Nacional de Cardiología Dr. Ignacio Chávez, Endocrinology Department, Mexico City, Mexico. Date of submission: 20/06/2016 Date of Approval: 30/10/2016 of bullae development and symptoms relapse. Furthermore, the material used for ASP has a lower cost than the one used for AQ, which could represent an economic advantage for patients that attend our Hospital.