Cataract, Glaucoma, Open-Angle
Conditions
Brief summary
This study was carried out to evaluate the safety and efficacy of combined phacoemulsification and Ultrasound ciliary plasty (Phaco-UCP) as a first-line surgical treatment of coexisting cataract and op /en angle glaucoma compared to phacoemulsification alone. To our knowledge, this is the first report of results of combined Phaco-UCP
Detailed description
the study involved 61 eyes of 61 patients with coexisting cataract and open angle glaucoma, 31 eyes were managed with Phaco-UCP and 30 eyes of age and sex matched patients were managed with phacoemulsification alone. Patients were randomized for either combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP) (the study group) or phacoemulsification alone (the control group). All surgeries were performed by one experienced surgeon (Y EZ). Preoperative evaluation included manifest refraction, BCVA measurement, slit-lamp biomicroscopy, gonioscopy, indirect ophthalmoscopy, measurement of IOP with Goldmann applanation tonometry (average of 3 readings taken). Corneal diameter (White-to-white) and axial length measurement were done using IOL Master 500 (Carl Zeiss Meditec AG., Germany). Ultrasound pachymetry with Tomey SP-100 (Tomey Corp. Nagoya, Japan) and visual fields using Humphrey Field Analyzer (24-2, SITA, standard program Carl Zeiss Meditec AG., Germany) were also performed.
Interventions
PROCEDUREcombined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP)
performing ultrasound ciliary plasty then performing standard phacoemulsification
PROCEDUREPhacoemulsification alone
standard phacoemulsification for catarct extraction
Sponsors
Dar Alshifa hospital Kuwait
Ameera Gamal Abdelhameed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients diagnosed with POAG or pseudoexfoliation glaucoma with coexisting visually significant cataract that required phacoemulsification
Exclusion criteria
* patients with any other type of glaucoma, including narrow angle glaucoma, neovascular, uveitic or angle recession glaucoma, patients with advanced glaucoma characterized by advanced optic disc cupping or visual field damage, history of glaucoma or intraocular surgery and other ocular diseases that would affect safety or interfere with the procedure. We also excluded patients with incomplete follow-up or missing data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reduction in intraocular pressure | 18 months postoperative | Qualified Success was defined as an IOP reduction of at least 20 % from baseline value, with an IOP that is between 6 - 21 mm Hg, without the need for additional antiglaucoma medications or glaucoma surgery |
| reduction in r the number of antiglaucoma medications. | 18 months postoperative | reduction of the number of antiglaucoma medication or at least no increase in the number |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BCVA improvement | 18 months postoperative | improvement of best corrected visual acuity |
| intraoperative and postoperative complications. | intraoperative and 18 months postoperative | hyphema or vitreous hemorrhage necessitating surgical intervention, choroidal hemorrhage, chronic uveitis, endophthalmitis, hypotony (IOP ≤ 5 mm Hg), phthisis, IOL dislocation, and retinal detachment. |
Countries
Egypt
Outcome results
None listed