Glaucoma, Angle-ClosurePHEPHANCT04562402
Phaco-ECP vs Phaco Alone in Primary Angle Closure
A study testing Phacoemulsification and Endoscopic cyclophotocoagulation in people with Glaucoma, Angle-Closure, run by King Khaled Eye Specialist Hospital at 1 site in Saudi Arabia.
Trial summary
Comparison between phacoemulsification with endoscopic cyclophotocoagulation versus phacoemulsification alone in patients with either primary angle closure or primary angle closure glaucoma presenting with cataract or a clear lens. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Glaucoma, Angle-Closure
- What is being tested?
- Phacoemulsification and Endoscopic cyclophotocoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 16 Aug 2020to 15 Feb 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age is above 40 years old.
- A diagnosis of either PAC or PACG. PAC will be defined as the presence of irido-trabecular contact on gonioscopy, either appositional or in the presence of peripheral anterior synechiae (PAS), without indentation (or prior documentation before a LPI has been performed) without any evidence of glaucomatous optic neuropathy. PACG will be defined as PAC along with an evidence of glaucomatous optic neuropathy. An optic neuropathy secondary to glaucoma will be defined as evidence of structural and functional damage suggestive of glaucoma as demonstrated by clinical examination, optical coherence tomography, and visual field testing.
- IOP measurement that is more than 21 mmHg (not exceeding 35 mmHg) without the use of glaucoma medications or less than 21 mmHg with medications.
- Patient is able to give an informed consent and tolerate a period of medication washout.
Who cannot join
- Previous intraocular surgery (including CPC). Glaucoma laser procedures are allowed (e.g. LPI, iridoplasty, and laser trabeculoplasty).
- Previous ocular trauma.
- A central corneal thickness that does not lie between 500 and 600 microns.
- A diagnosis of nanophthalmos (defined as an axial length that is less than 20 mm).
- Presence of pseudoexfoliation.
- Presence of secondary causes of angle closure such as neovascular glaucoma and uveitic glaucoma.
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- Presence of diabetic retinopathy (active PDR or active DME) or agerelated macular degeneration. PHEPHA Protocol Version 2 September 3, 2020
- Advanced glaucoma as defined by the Glaucoma Severity Staging System12 (mean deviation worse than -12.01 dB and at least one of the following: 1. On pattern deviation plot, greater than or equal to 50% but fewer than 75% of points depressed below the 5% level and greater than or equal to 25% but fewer than 50% of points depressed below 1% level 2. Any point within central 5 degrees with sensitivity < 0db 3. Both hemifields containing a point(s) with sensitivity < 15 dB within 5 degrees of fixation).
- Any ocular or systemic condition that is presumed to prevent reliable clinical examination and/or visual field testing.
- Pregnancy.
- Inability to attend postoperative follow ups for a period of 12 months after surgery.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Khaled Eye Specialist Hospital
Riyadh, 11462
Muneera AlFutais, +966114849700 ext. 1374, mfutais@kkesh.med.sa
Adi Al Owaifeer, MBBS
About this study
Official title: Phacoemulsification With Endoscopic Cyclophotocoagulation vs Phacoemulsification Alone in Primary Angle Closure (PHEPHA): A Randomized Clinical Trial
Comparison between phacoemulsification with endoscopic cyclophotocoagulation versus phacoemulsification alone in patients with either primary angle closure or primary angle closure glaucoma presenting with cataract or a clear lens.
Read the detailed description
The purpose of our current randomized clinical trial is to compare phacoemulsification with endoscopic cyclophotocoagulation (PHE) versus phacoemulsification alone (PHA) in patients with either primary angle closure (PAC) or primary angle closure glaucoma (PACG) presenting with cataract or a clear lens.
- Conditions
- Glaucoma, Angle-Closure
- Being tested
- Phacoemulsification, Endoscopic cyclophotocoagulation
- Keywords
- Glaucoma, Endoscopic cyclophotocoagulation, Laser, Intraocular pressure, Phacoemulsification, Primary angle closure glaucoma
- Medical subject headings
- Glaucoma, Angle-Closure, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhacoemulsificationProcedure or surgery
cataract surgery via phacoemulsification
Endoscopic cyclophotocoagulationProcedure or surgery
Endoscopic ablation of the ciliary body
| Study group | Role | What they receive |
|---|---|---|
| Phacoemulsification with endoscopic cyclophotocoagulation | Active comparator | Cataract extraction via phacoemulsification along with endoscopic cyclophotocoagulation of the ciliary body. Receives: Procedure: Phacoemulsification; Procedure: Endoscopic cyclophotocoagulation |
| Phacoemulsification alone | Active comparator | Cataract extraction via phacoemulsification. Receives: Procedure: Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
Change in IOP between baseline (pre-intervention) and the last follow-up visit
Measured: 12 months
Number of glaucoma medications
Change in the number of glaucoma medications between baseline (pre-intervention) and the last follow-up visit
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start16 Aug 2020
- Primary completion15 Feb 2022 (estimated)
- Study completion15 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Angle-ClosureStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Khaled Eye Specialist Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Adi Al Owaifeer, MBBS, King Khaled Eye Specialist Hospital
- Investigators
- Adi Al Owaifeer, MBBS, Principal investigator, King Khaled Eye Specialist HospitalIbrahim Alobaida, MD, Principal investigator, King Khaled Eye Specialist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562402
- Sponsor's protocol ID
- 1956-P
- Acronym
- PHEPHA
- Status last verified
- Sep 2020
- First submitted
- 18 Sep 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phacoemulsification With Endoscopic Cyclophotocoagulation vs Phacoemulsification Alone in Primary Angle Closure (PHEPHA): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04562402
- Acronym / sponsor ID
- PHEPHA / 1956-P
- Conditions
- Glaucoma, Angle-Closure
- Keywords
- Glaucoma, Endoscopic cyclophotocoagulation, Laser, Intraocular pressure, Phacoemulsification, Primary angle closure glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- King Khaled Eye Specialist HospitalOther government
- Study start
- 16 Aug 2020 (actual)
- Primary completion
- 15 Feb 2022 (estimated)
- Study completion
- 15 Feb 2022 (estimated)
- First posted
- 24 Sep 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.
Comparison between phacoemulsification with endoscopic cyclophotocoagulation versus phacoemulsification alone in patients with either primary angle closure or primary angle closure glaucoma presenting with cataract or a clear lens.
Detailed description
The purpose of our current randomized clinical trial is to compare phacoemulsification with endoscopic cyclophotocoagulation (PHE) versus phacoemulsification alone (PHA) in patients with either primary angle closure (PAC) or primary angle closure glaucoma (PACG) presenting with cataract or a clear lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phacoemulsification with endoscopic cyclophotocoagulation | Active comparator | Procedure: Phacoemulsification, Procedure: Endoscopic cyclophotocoagulationCataract extraction via phacoemulsification along with endoscopic cyclophotocoagulation of the ciliary body. |
| Phacoemulsification alone | Active comparator | Procedure: PhacoemulsificationCataract extraction via phacoemulsification. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age is above 40 years old.
- A diagnosis of either PAC or PACG. PAC will be defined as the presence of irido-trabecular contact on gonioscopy, either appositional or in the presence of peripheral anterior synechiae (PAS), without indentation (or prior documentation before a LPI has been performed) without any evidence of glaucomatous optic neuropathy. PACG will be defined as PAC along with an evidence of glaucomatous optic neuropathy. An optic neuropathy secondary to glaucoma will be defined as evidence of structural and functional damage suggestive of glaucoma as demonstrated by clinical examination, optical coherence tomography, and visual field testing.
- IOP measurement that is more than 21 mmHg (not exceeding 35 mmHg) without the use of glaucoma medications or less than 21 mmHg with medications.
- Patient is able to give an informed consent and tolerate a period of medication washout.
Key exclusion criteria (11 listed)
- Previous intraocular surgery (including CPC). Glaucoma laser procedures are allowed (e.g. LPI, iridoplasty, and laser trabeculoplasty).
- Previous ocular trauma.
- A central corneal thickness that does not lie between 500 and 600 microns.
- A diagnosis of nanophthalmos (defined as an axial length that is less than 20 mm).
- Presence of pseudoexfoliation.
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 |
|---|---|---|
| Phacoemulsificationcataract surgery via phacoemulsification | Procedure or surgery | Phacoemulsification alone, Phacoemulsification with endoscopic cyclophotocoagulation |
| Endoscopic cyclophotocoagulationEndoscopic ablation of the ciliary body | Procedure or surgery | Phacoemulsification with endoscopic cyclophotocoagulation |
Primary outcome
Intraocular Pressure (IOP)
Time frame: 12 months
Change in IOP between baseline (pre-intervention) and the last follow-up visit
Number of glaucoma medications
Time frame: 12 months
Change in the number of glaucoma medications between baseline (pre-intervention) and the last follow-up visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Adi Al Owaifeer, MBBS principal investigator
King Khaled Eye Specialist Hospital
Ibrahim Alobaida, MD principal investigator
King Khaled Eye Specialist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phacoemulsification and Endoscopic cyclophotocoagulation in people with Glaucoma, Angle-Closure, run by King Khaled Eye Specialist Hospital at 1 site in Saudi Arabia.
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 24 Sep 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 Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muneera AlFutais (+966114849700 ext. 1374, mfutais@kkesh.med.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure (IOP) (time frame: 12 months). 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?
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 24 Sep 2020.