search
Back to results

Phaco-UCP Versus Phaco Alone for OAG and Cataract

Primary Purpose

Cataract, Glaucoma, Open-Angle

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP)
Phacoemulsification alone
Sponsored by
Ameera Gamal Abdelhameed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

phaco-UCP

Phaco alone

Arm Description

Under peribulbar anesthesia, UCP was performed first, followed by phacoemulsification. UCP was performed using the same technique described before [18]. For all treatments, 2nd generation probe was used (EyeOP1, Eye Tech care; France) with the same parameters; Operating frequency was 21 MHz. Number of sectors activated was 6. Acoustic power was 2.45 W; duration of each shot was 8s; and the time between shots was 20s. The probe diameter (11, 12 or 13 mm) was determined according to the eye's biometric readings. The coupling cone was centered on the eye and kept in place with low vacuum suction, followed by introduction of the treatment probe inside the cone, then activation of the transducers by constantly pressing the foot switch. Once UCP treatment was finished, phacoemulsification was commenced

A standard phacoemulsification was performed with 2.2 mm clear corneal incision, continuous curvilinear capsulorhexis, phacoemulsification and intrabagal implantation of foldable acrylic intraocular lens (AcrySof® IQ SN60WF monofocal; Alcon Laboratories Inc, Fort Worth, TX, USA) for all patients. Irrigation-aspiration was performed for at least 30 seconds to remove any viscoelastic from the anterior chamber. Reformation of the anterior chamber was done with balanced saline solution (BSS), followed by hydration of the corneal wound and side port.

Outcomes

Primary Outcome Measures

reduction in intraocular pressure
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.
reduction of the number of antiglaucoma medication or at least no increase in the number

Secondary Outcome Measures

BCVA improvement
improvement of best corrected visual acuity
intraoperative and postoperative complications.
hyphema or vitreous hemorrhage necessitating surgical intervention, choroidal hemorrhage, chronic uveitis, endophthalmitis, hypotony (IOP ≤ 5 mm Hg), phthisis, IOL dislocation, and retinal detachment.

Full Information

First Posted
June 9, 2020
Last Updated
June 11, 2020
Sponsor
Ameera Gamal Abdelhameed
Collaborators
Dar Alshifa hospital Kuwait
search

1. Study Identification

Unique Protocol Identification Number
NCT04430647
Brief Title
Phaco-UCP Versus Phaco Alone for OAG and Cataract
Official Title
Phaco-UCP; Combined Phacoemulsification and Ultrasound Ciliary Plasty Versus Phacoemulsification Alone for Management of Coexisting Cataract and Open Angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ameera Gamal Abdelhameed
Collaborators
Dar Alshifa hospital Kuwait

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Glaucoma, Open-Angle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
phaco-UCP
Arm Type
Experimental
Arm Description
Under peribulbar anesthesia, UCP was performed first, followed by phacoemulsification. UCP was performed using the same technique described before [18]. For all treatments, 2nd generation probe was used (EyeOP1, Eye Tech care; France) with the same parameters; Operating frequency was 21 MHz. Number of sectors activated was 6. Acoustic power was 2.45 W; duration of each shot was 8s; and the time between shots was 20s. The probe diameter (11, 12 or 13 mm) was determined according to the eye's biometric readings. The coupling cone was centered on the eye and kept in place with low vacuum suction, followed by introduction of the treatment probe inside the cone, then activation of the transducers by constantly pressing the foot switch. Once UCP treatment was finished, phacoemulsification was commenced
Arm Title
Phaco alone
Arm Type
Active Comparator
Arm Description
A standard phacoemulsification was performed with 2.2 mm clear corneal incision, continuous curvilinear capsulorhexis, phacoemulsification and intrabagal implantation of foldable acrylic intraocular lens (AcrySof® IQ SN60WF monofocal; Alcon Laboratories Inc, Fort Worth, TX, USA) for all patients. Irrigation-aspiration was performed for at least 30 seconds to remove any viscoelastic from the anterior chamber. Reformation of the anterior chamber was done with balanced saline solution (BSS), followed by hydration of the corneal wound and side port.
Intervention Type
Procedure
Intervention Name(s)
combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP)
Intervention Description
performing ultrasound ciliary plasty then performing standard phacoemulsification
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification alone
Intervention Description
standard phacoemulsification for catarct extraction
Primary Outcome Measure Information:
Title
reduction in intraocular pressure
Description
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
Time Frame
18 months postoperative
Title
reduction in r the number of antiglaucoma medications.
Description
reduction of the number of antiglaucoma medication or at least no increase in the number
Time Frame
18 months postoperative
Secondary Outcome Measure Information:
Title
BCVA improvement
Description
improvement of best corrected visual acuity
Time Frame
18 months postoperative
Title
intraoperative and postoperative complications.
Description
hyphema or vitreous hemorrhage necessitating surgical intervention, choroidal hemorrhage, chronic uveitis, endophthalmitis, hypotony (IOP ≤ 5 mm Hg), phthisis, IOL dislocation, and retinal detachment.
Time Frame
intraoperative and 18 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magda Torky, MD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University
City
Mansoura
State/Province
Dakahlia
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
22133988
Citation
Pascolini D, Mariotti SP. Global estimates of visual impairment: 2010. Br J Ophthalmol. 2012 May;96(5):614-8. doi: 10.1136/bjophthalmol-2011-300539. Epub 2011 Dec 1.
Results Reference
background
PubMed Identifier
25775362
Citation
Chen DZ, Koh V, Sng C, Aquino MC, Chew P. Complications and outcomes of primary phacotrabeculectomy with mitomycin C in a multi-ethnic asian population. PLoS One. 2015 Mar 16;10(3):e0118852. doi: 10.1371/journal.pone.0118852. eCollection 2015.
Results Reference
background
PubMed Identifier
25624668
Citation
Kung JS, Choi DY, Cheema AS, Singh K. Cataract surgery in the glaucoma patient. Middle East Afr J Ophthalmol. 2015 Jan-Mar;22(1):10-7. doi: 10.4103/0974-9233.148343.
Results Reference
background
PubMed Identifier
26895293
Citation
Parikh HA, Bussel II, Schuman JS, Brown EN, Loewen NA. Coarsened Exact Matching of Phaco-Trabectome to Trabectome in Phakic Patients: Lack of Additional Pressure Reduction from Phacoemulsification. PLoS One. 2016 Feb 19;11(2):e0149384. doi: 10.1371/journal.pone.0149384. eCollection 2016.
Results Reference
background
PubMed Identifier
23628350
Citation
Yang HS, Lee J, Choi S. Ocular biometric parameters associated with intraocular pressure reduction after cataract surgery in normal eyes. Am J Ophthalmol. 2013 Jul;156(1):89-94.e1. doi: 10.1016/j.ajo.2013.02.003. Epub 2013 Apr 28.
Results Reference
background
PubMed Identifier
29412193
Citation
Lin SC, Masis M, Porco TC, Pasquale LR. Erratum: Predictors of Intraocular Pressure After Phacoemulsification in Primary Open-Angle Glaucoma Eyes with Wide Versus Narrower Angles (An American Ophthalmological Society Thesis). Trans Am Ophthalmol Soc. 2018 Jan 1;115:T6C1. eCollection 2017 Aug.
Results Reference
background
PubMed Identifier
30787680
Citation
Baek SU, Kwon S, Park IW, Suh W. Effect of Phacoemulsification on Intraocular Pressure in Healthy Subjects and Glaucoma Patients. J Korean Med Sci. 2019 Jan 30;34(6):e47. doi: 10.3346/jkms.2019.34.e47. eCollection 2019 Feb 18.
Results Reference
background
PubMed Identifier
17361241
Citation
O'Brien PD, Ho SL, Fitzpatrick P, Power W. Risk factors for a postoperative intraocular pressure spike after phacoemulsification. Can J Ophthalmol. 2007 Feb;42(1):51-5.
Results Reference
background
PubMed Identifier
29516042
Citation
Potop V, Corbu C. The role of clear lens extraction in angle closure glaucoma. Rom J Ophthalmol. 2017 Oct-Dec;61(4):244-248.
Results Reference
background
PubMed Identifier
30681574
Citation
Chen HY, Lin CL, Kao CH. Changes in glaucoma medication numbers after cataract and glaucoma surgery: A nationwide population-based study. Medicine (Baltimore). 2019 Jan;98(4):e14128. doi: 10.1097/MD.0000000000014128.
Results Reference
background
PubMed Identifier
14743022
Citation
Vass C, Menapace R. Surgical strategies in patients with combined cataract and glaucoma. Curr Opin Ophthalmol. 2004 Feb;15(1):61-6. doi: 10.1097/00055735-200402000-00012.
Results Reference
background
PubMed Identifier
26337945
Citation
Mercieca K, Shevade B, Anand N. Outcomes of combined phacoemulsification and deep sclerectomy: a 10-year UK single-centre study. Eye (Lond). 2015 Nov;29(11):1495-503. doi: 10.1038/eye.2015.163. Epub 2015 Sep 4.
Results Reference
background
Citation
Francis BA, Sarkisian SR, Tan JC (2017). Minimally invasive glaucoma surgery: A practical guide. 1st ed. New York: Thieme.
Results Reference
background
PubMed Identifier
25982212
Citation
Melamed S, Goldenfeld M, Cotlear D, Skaat A, Moroz I. High-intensity focused ultrasound treatment in refractory glaucoma patients: results at 1 year of prospective clinical study. Eur J Ophthalmol. 2015 Nov-Dec;25(6):483-9. doi: 10.5301/ejo.5000620. Epub 2015 May 13.
Results Reference
background
PubMed Identifier
28512580
Citation
Mastropasqua R, Fasanella V, Mastropasqua A, Ciancaglini M, Agnifili L. High-Intensity Focused Ultrasound Circular Cyclocoagulation in Glaucoma: A Step Forward for Cyclodestruction? J Ophthalmol. 2017;2017:7136275. doi: 10.1155/2017/7136275. Epub 2017 Apr 22.
Results Reference
background
PubMed Identifier
29768281
Citation
Giannaccare G, Vagge A, Sebastiani S, Urbini LE, Corazza P, Pellegrini M, Carmassi L, Bergamini F, Traverso CE, Campos EC. Ultrasound Cyclo-Plasty in Patients with Glaucoma: 1-Year Results from a Multicentre Prospective Study. Ophthalmic Res. 2019;61(3):137-142. doi: 10.1159/000487953. Epub 2018 May 16.
Results Reference
background
PubMed Identifier
19674729
Citation
Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL; Tube Versus Trabeculectomy Study Group. Three-year follow-up of the tube versus trabeculectomy study. Am J Ophthalmol. 2009 Nov;148(5):670-84. doi: 10.1016/j.ajo.2009.06.018. Epub 2009 Aug 11.
Results Reference
background
PubMed Identifier
25088629
Citation
Francis BA, Berke SJ, Dustin L, Noecker R. Endoscopic cyclophotocoagulation combined with phacoemulsification versus phacoemulsification alone in medically controlled glaucoma. J Cataract Refract Surg. 2014 Aug;40(8):1313-21. doi: 10.1016/j.jcrs.2014.06.021.
Results Reference
background
PubMed Identifier
3991121
Citation
Coleman DJ, Lizzi FL, Driller J, Rosado AL, Chang S, Iwamoto T, Rosenthal D. Therapeutic ultrasound in the treatment of glaucoma. I. Experimental model. Ophthalmology. 1985 Mar;92(3):339-46. doi: 10.1016/s0161-6420(85)34029-0.
Results Reference
background
PubMed Identifier
29043438
Citation
De Gregorio A, Pedrotti E, Stevan G, Montali M, Morselli S. Safety and efficacy of multiple cyclocoagulation of ciliary bodies by high-intensity focused ultrasound in patients with glaucoma. Graefes Arch Clin Exp Ophthalmol. 2017 Dec;255(12):2429-2435. doi: 10.1007/s00417-017-3817-4. Epub 2017 Oct 17.
Results Reference
background
PubMed Identifier
30809493
Citation
Pellegrini M, Sebastiani S, Giannaccare G, Campos EC. Intraocular inflammation after Ultrasound Cyclo Plasty for the treatment of glaucoma. Int J Ophthalmol. 2019 Feb 18;12(2):338-341. doi: 10.18240/ijo.2019.02.23. eCollection 2019.
Results Reference
background
PubMed Identifier
31024813
Citation
Torky MA, Al Zafiri YA, Hagras SM, Khattab AM, Bassiouny RM, Mokbel TH. Safety and efficacy of ultrasound ciliary plasty as a primary intervention in glaucoma patients. Int J Ophthalmol. 2019 Apr 18;12(4):597-602. doi: 10.18240/ijo.2019.04.12. eCollection 2019.
Results Reference
background
PubMed Identifier
30140647
Citation
Sun W, Yu CY, Tong JP. A review of combined phacoemulsification and endoscopic cyclophotocoagulation: efficacy and safety. Int J Ophthalmol. 2018 Aug 18;11(8):1396-1402. doi: 10.18240/ijo.2018.08.23. eCollection 2018.
Results Reference
background
PubMed Identifier
29077182
Citation
Perez Bartolome F, Rodrigues IA, Goyal S, Bloch E, Lim WS, Alaghband P, Guajardo J, Jones S, Lim KS. Phacoemulsification plus endoscopic cyclophotocoagulation versus phacoemulsification alone in primary open-angle glaucoma. Eur J Ophthalmol. 2018 Mar;28(2):168-174. doi: 10.5301/ejo.5001034.
Results Reference
background
PubMed Identifier
31550914
Citation
Hugo J, Matonti F, Beylerian M, Zanin E, Aptel F, Denis D. Safety and efficacy of high-intensity focused ultrasound in severe or refractory glaucoma. Eur J Ophthalmol. 2021 Jan;31(1):130-137. doi: 10.1177/1120672119874594. Epub 2019 Sep 25.
Results Reference
background
PubMed Identifier
21437758
Citation
Heinz C, Zurek-Imhoff B, Koch J, Rosel M, Heiligenhaus A. Long-term reduction of laser flare values after trabeculectomy but not after cyclodestructive procedures in uveitis patients. Int Ophthalmol. 2011 Jun;31(3):205-10. doi: 10.1007/s10792-011-9440-1. Epub 2011 Mar 25.
Results Reference
background
PubMed Identifier
20447122
Citation
Tan AM, Chockalingam M, Aquino MC, Lim ZI, See JL, Chew PT. Micropulse transscleral diode laser cyclophotocoagulation in the treatment of refractory glaucoma. Clin Exp Ophthalmol. 2010 Apr;38(3):266-72. doi: 10.1111/j.1442-9071.2010.02238.x.
Results Reference
background
PubMed Identifier
24811050
Citation
Aquino MC, Barton K, Tan AM, Sng C, Li X, Loon SC, Chew PT. Micropulse versus continuous wave transscleral diode cyclophotocoagulation in refractory glaucoma: a randomized exploratory study. Clin Exp Ophthalmol. 2015 Jan-Feb;43(1):40-6. doi: 10.1111/ceo.12360. Epub 2014 Jun 21.
Results Reference
background
PubMed Identifier
8196935
Citation
Liu GJ, Mizukawa A, Okisaka S. Mechanism of intraocular pressure decrease after contact transscleral continuous-wave Nd:YAG laser cyclophotocoagulation. Ophthalmic Res. 1994;26(2):65-79. doi: 10.1159/000267395.
Results Reference
background
PubMed Identifier
31354201
Citation
Sousa DC, Ferreira NP, Marques-Neves C, Somers A, Vandewalle E, Stalmans I, Pinto LA. High-intensity Focused Ultrasound Cycloplasty: Analysis of Pupil Dynamics. J Curr Glaucoma Pract. 2018 Sep-Dec;12(3):102-106. doi: 10.5005/jp-journals-10028-1253.
Results Reference
background
PubMed Identifier
31564798
Citation
Rivero-Santana A, Perez-Silguero D, Perez-Silguero MA, Encinas-Pisa P. Pupil Ovalization and Accommodation Loss after High-intensity Focused Ultrasound Treatment for Glaucoma: A Case Report. J Curr Glaucoma Pract. 2019 May-Aug;13(2):77-78. doi: 10.5005/jp-journals-10078-1256.
Results Reference
background
Citation
Bolek, B., Wylegala, A., Mazur, R. and Wylegala, E. (2019), Pupil irregularity after ultrasound ciliary plasty in glaucoma treatment. Acta Ophthalmol, 97:. doi:10.1111/j.1755-3768.2019.5480
Results Reference
background
PubMed Identifier
29582811
Citation
Deb-Joardar N, Reddy KP. Application of high intensity focused ultrasound for treatment of open-angle glaucoma in Indian patients. Indian J Ophthalmol. 2018 Apr;66(4):517-523. doi: 10.4103/ijo.IJO_1024_17.
Results Reference
background
PubMed Identifier
33478426
Citation
Torky MA, Alzafiri YA, Abdelhameed AG, Awad EA. Phaco-UCP; combined phacoemulsification and ultrasound ciliary plasty versus phacoemulsification alone for management of coexisting cataract and open angle glaucoma: a randomized clinical trial. BMC Ophthalmol. 2021 Jan 21;21(1):53. doi: 10.1186/s12886-021-01818-5.
Results Reference
derived

Learn more about this trial

Phaco-UCP Versus Phaco Alone for OAG and Cataract

We'll reach out to this number within 24 hrs