CataractNCT04430647
Phaco-UCP Versus Phaco Alone for OAG and Cataract
A study testing combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP) and Phacoemulsification alone in people with Cataract and Glaucoma, Open-Angle, run by Ameera Gamal Abdelhameed at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cataract, Glaucoma, Open-Angle
- What is being tested?
- combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP) and Phacoemulsification alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with POAG or pseudoexfoliation glaucoma with coexisting visually significant cataract that required phacoemulsification
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phaco-UCP; Combined Phacoemulsification and Ultrasound Ciliary Plasty Versus Phacoemulsification Alone for Management of Coexisting Cataract and Open Angle Glaucoma
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
Read the 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.
- Conditions
- Cataract, Glaucoma, Open-Angle
- Being tested
- combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP), Phacoemulsification alone
- Medical subject headings
- Cataract, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP)Procedure or surgery
performing ultrasound ciliary plasty then performing standard phacoemulsification
Phacoemulsification aloneProcedure or surgery
standard phacoemulsification for catarct extraction
| Study group | Role | What they receive |
|---|---|---|
| phaco-UCP | Experimental | 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 Receives: Procedure: combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP) |
| Phaco alone | Active comparator | 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. Receives: Procedure: Phacoemulsification alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months postoperative
reduction in r the number of antiglaucoma medications.
reduction of the number of antiglaucoma medication or at least no increase in the number
Measured: 18 months postoperative
Secondary outcomes (2)
BCVA improvement
improvement of best corrected visual acuity
Measured: 18 months postoperative
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.
Measured: intraoperative and 18 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 Mar 2018
- Primary completion1 Sep 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ameera Gamal Abdelhameed
- Sponsor type
- University, hospital or other
- Collaborators
- Dar Alshifa hospital Kuwait
- Responsible party
- Sponsor-investigator, Ameera Gamal Abdelhameed, Mansoura University
- Investigators
- Magda Torky, MD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430647
- Sponsor's protocol ID
- Phaco-UCP in OAG and cataract
- Status last verified
- Jun 2020
- First submitted
- 9 Jun 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22133988Chen 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.
PubMed 25775362Kung 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.
PubMed 25624668Parikh 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.
PubMed 26895293Yang 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.
PubMed 23628350Lin 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.
PubMed 29412193Baek 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.
PubMed 30787680O'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.
PubMed 17361241Potop V, Corbu C. The role of clear lens extraction in angle closure glaucoma. Rom J Ophthalmol. 2017 Oct-Dec;61(4):244-248.
PubMed 29516042Chen 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.
PubMed 30681574Vass 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.
PubMed 14743022Mercieca 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.
PubMed 26337945Francis BA, Sarkisian SR, Tan JC (2017). Minimally invasive glaucoma surgery: A practical guide. 1st ed. New York: Thieme.
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.
PubMed 25982212Mastropasqua 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.
PubMed 28512580
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phaco-UCP; Combined Phacoemulsification and Ultrasound Ciliary Plasty Versus Phacoemulsification Alone for Management of Coexisting Cataract and Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT04430647
- Acronym / sponsor ID
- Phaco-UCP in OAG and cataract
- Conditions
- Cataract, Glaucoma, Open-Angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ameera Gamal AbdelhameedUniversity, hospital or other
- Collaborators
- Dar Alshifa hospital Kuwait
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| phaco-UCP | Experimental | Procedure: combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP)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 |
| Phaco alone | Active comparator | Procedure: Phacoemulsification aloneA 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed with POAG or pseudoexfoliation glaucoma with coexisting visually significant cataract that required phacoemulsification
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP)performing ultrasound ciliary plasty then performing standard phacoemulsification | Procedure or surgery | phaco-UCP |
| Phacoemulsification alonestandard phacoemulsification for catarct extraction | Procedure or surgery | Phaco alone |
Primary outcome
reduction in intraocular pressure
Time frame: 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.
Time frame: 18 months postoperative
reduction of the number of antiglaucoma medication or at least no increase in the number
2 secondary outcomes
BCVA improvement
Time frame: 18 months postoperative
intraoperative and postoperative complications.
Time frame: intraoperative and 18 months postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Background: PubMed 22133988Pascolini 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.
- Background: PubMed 25775362Chen 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.
- Background: PubMed 25624668Kung 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.
- Background: PubMed 26895293Parikh 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.
- Background: PubMed 23628350Yang 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.
- Background: PubMed 29412193Lin 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.
- Background: PubMed 30787680Baek 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.
- Background: PubMed 17361241O'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.
- Background: PubMed 29516042Potop V, Corbu C. The role of clear lens extraction in angle closure glaucoma. Rom J Ophthalmol. 2017 Oct-Dec;61(4):244-248.
- Background: PubMed 30681574Chen 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.
- Background: PubMed 14743022Vass 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.
- Background: PubMed 26337945Mercieca 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.
Related trials for Cataract
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
Recruiting
Clinical Evaluation of a Novel Trifocal IOL
Aphakia, Cataract
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Not yet recruitingObservational study
Postoperative Outcome Verification of Discrepant Toric IOL Calculator Recommendations After Cataract Surgery
Cataract
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magda Torky, MD principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP) and Phacoemulsification alone in people with Cataract and Glaucoma, Open-Angle, run by Ameera Gamal Abdelhameed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in intraocular pressure (time frame: 18 months postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04430647, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.