Magda A Torky1, Yousef A Alzafiri2, Ameera G Abdelhameed3, Eman A Awad1. 1. Department of Ophthalmology, Mansoura Ophthalmic Center, Faculty of medicine, Mansoura University, Al-Gomhoria Street, Mansoura, 35516, Egypt. 2. Department of Ophthalmology, Dar Al Shifa hospital, 30000, Hawally City, Kuwait. 3. Department of Ophthalmology, Mansoura Ophthalmic Center, Faculty of medicine, Mansoura University, Al-Gomhoria Street, Mansoura, 35516, Egypt. amiragamal287@gmail.com.
Abstract
BACKGROUND: Various surgical techniques have been described, to be combined with cataract surgery in glaucoma patients, aiming for an additional reduction of intraocular pressure (IOP), hence minimizing the burden of anti-glaucoma medication (AGM). Ultrasound ciliary plasty (UCP) is a recent microinvasive glaucoma surgery (MIGS) recommended for primary and refractory glaucoma. This study was conducted to evaluate the safety and efficacy of a new technique; combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP) as a primary surgical treatment for coexisting cataract and open angle glaucoma. METHODS: A randomized clinical trial, including 61 eyes of 61 patients with visually significant cataract and open angle glaucoma, randomized to eitherPhaco-UCP (study group; 31 eyes) or phacoemulsification alone (Phaco-alone) (control group; 30 eyes). Primary outcomes included reduction in IOP and/or the number of AGM. Secondary outcomes included visual acuity improvement and complications. Qualified Success was defined as an IOP reduction ≥ 20% from baseline value, with an IOP 6-21 mmHg, with no additional AGM or glaucoma surgery. Failure was defined as either < 20% IOP reduction, despite AGM use, the need of glaucoma surgeries or serious complications. RESULTS: At 18 months postoperatively, Phaco-UCP group had a median IOP reduction of 7 mmHg (Q1, Q3 = 3, 10) compared to 2 mmHg (Q1, Q3 = 2, 3) in Phaco-alone group (P < 0.001). Phaco-UCP group had significantly higher success rate at all time points reaching 67.7% at the last follow-up versus 16.7% only in Phaco-alone group (P< 0.001). The median number of AGM significantly decreased from [3 (Q1, Q3 = 2, 4), 3 (Q1, Q3 = 2,3)] respectively, (P =0.3)] at baseline to [1 (Q1,Q3 = 1, 2), 2 (Q1,Q3 = 2, 2)] respectively, (P < 0.001)] at 18 months postoperatively. No serious intraoperative or postoperative complications were encountered in either group. CONCLUSION:Phaco-UCP is a simple, safe and effective procedure for management of coexisting cataract and open angle glaucoma. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04430647 ; retrospectively registered. June 12, 2020.
RCT Entities:
BACKGROUND: Various surgical techniques have been described, to be combined with cataract surgery in glaucomapatients, aiming for an additional reduction of intraocular pressure (IOP), hence minimizing the burden of anti-glaucoma medication (AGM). Ultrasound ciliary plasty (UCP) is a recent microinvasive glaucoma surgery (MIGS) recommended for primary and refractory glaucoma. This study was conducted to evaluate the safety and efficacy of a new technique; combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP) as a primary surgical treatment for coexisting cataract and open angle glaucoma. METHODS: A randomized clinical trial, including 61 eyes of 61 patients with visually significant cataract and open angle glaucoma, randomized to either Phaco-UCP (study group; 31 eyes) or phacoemulsification alone (Phaco-alone) (control group; 30 eyes). Primary outcomes included reduction in IOP and/or the number of AGM. Secondary outcomes included visual acuity improvement and complications. Qualified Success was defined as an IOP reduction ≥ 20% from baseline value, with an IOP 6-21 mmHg, with no additional AGM or glaucoma surgery. Failure was defined as either < 20% IOP reduction, despite AGM use, the need of glaucoma surgeries or serious complications. RESULTS: At 18 months postoperatively, Phaco-UCP group had a median IOP reduction of 7 mmHg (Q1, Q3 = 3, 10) compared to 2 mmHg (Q1, Q3 = 2, 3) in Phaco-alone group (P < 0.001). Phaco-UCP group had significantly higher success rate at all time points reaching 67.7% at the last follow-up versus 16.7% only in Phaco-alone group (P< 0.001). The median number of AGM significantly decreased from [3 (Q1, Q3 = 2, 4), 3 (Q1, Q3 = 2,3)] respectively, (P =0.3)] at baseline to [1 (Q1,Q3 = 1, 2), 2 (Q1,Q3 = 2, 2)] respectively, (P < 0.001)] at 18 months postoperatively. No serious intraoperative or postoperative complications were encountered in either group. CONCLUSION: Phaco-UCP is a simple, safe and effective procedure for management of coexisting cataract and open angle glaucoma. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04430647 ; retrospectively registered. June 12, 2020.
Authors: Giuseppe Giannaccare; Aldo Vagge; Stefano Sebastiani; Lara E Urbini; Paolo Corazza; Marco Pellegrini; Luciana Carmassi; Fulvio Bergamini; Carlo E Traverso; Emilio C Campos Journal: Ophthalmic Res Date: 2018-05-16 Impact factor: 2.892