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Phaco-ECP vs Phaco Alone in Primary Angle Closure (PHEPHA)

Primary Purpose

Glaucoma, Angle-Closure

Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Phacoemulsification
Endoscopic cyclophotocoagulation
Sponsored by
King Khaled Eye Specialist Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Angle-Closure focused on measuring Glaucoma, Endoscopic cyclophotocoagulation, Laser, Intraocular pressure, Phacoemulsification, Primary angle closure glaucoma

Eligibility Criteria

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

Inclusion Criteria:

  1. Age is above 40 years old.
  2. 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.
  3. 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.
  4. Patient is able to give an informed consent and tolerate a period of medication washout.

Exclusion Criteria:

  1. Previous intraocular surgery (including CPC). Glaucoma laser procedures are allowed (e.g. LPI, iridoplasty, and laser trabeculoplasty).
  2. Previous ocular trauma.
  3. A central corneal thickness that does not lie between 500 and 600 microns.
  4. A diagnosis of nanophthalmos (defined as an axial length that is less than 20 mm).
  5. Presence of pseudoexfoliation.
  6. Presence of secondary causes of angle closure such as neovascular glaucoma and uveitic glaucoma.
  7. Presence of diabetic retinopathy (active PDR or active DME) or agerelated macular degeneration. PHEPHA Protocol Version 2 September 3, 2020
  8. 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).
  9. Any ocular or systemic condition that is presumed to prevent reliable clinical examination and/or visual field testing.
  10. Pregnancy.
  11. Inability to attend postoperative follow ups for a period of 12 months after surgery.

Sites / Locations

  • King Khaled Eye Specialist HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Phacoemulsification with endoscopic cyclophotocoagulation

Phacoemulsification alone

Arm Description

Cataract extraction via phacoemulsification along with endoscopic cyclophotocoagulation of the ciliary body.

Cataract extraction via phacoemulsification.

Outcomes

Primary Outcome Measures

Intraocular Pressure (IOP)
Change in IOP between baseline (pre-intervention) and the last follow-up visit
Number of glaucoma medications
Change in the number of glaucoma medications between baseline (pre-intervention) and the last follow-up visit

Secondary Outcome Measures

Full Information

First Posted
September 18, 2020
Last Updated
September 18, 2020
Sponsor
King Khaled Eye Specialist Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04562402
Brief Title
Phaco-ECP vs Phaco Alone in Primary Angle Closure
Acronym
PHEPHA
Official Title
Phacoemulsification With Endoscopic Cyclophotocoagulation vs Phacoemulsification Alone in Primary Angle Closure (PHEPHA): A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 16, 2020 (Actual)
Primary Completion Date
February 15, 2022 (Anticipated)
Study Completion Date
February 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Khaled Eye Specialist Hospital

4. Oversight

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

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Angle-Closure
Keywords
Glaucoma, Endoscopic cyclophotocoagulation, Laser, Intraocular pressure, Phacoemulsification, Primary angle closure glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phacoemulsification with endoscopic cyclophotocoagulation
Arm Type
Active Comparator
Arm Description
Cataract extraction via phacoemulsification along with endoscopic cyclophotocoagulation of the ciliary body.
Arm Title
Phacoemulsification alone
Arm Type
Active Comparator
Arm Description
Cataract extraction via phacoemulsification.
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification
Intervention Description
cataract surgery via phacoemulsification
Intervention Type
Procedure
Intervention Name(s)
Endoscopic cyclophotocoagulation
Intervention Description
Endoscopic ablation of the ciliary body
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Description
Change in IOP between baseline (pre-intervention) and the last follow-up visit
Time Frame
12 months
Title
Number of glaucoma medications
Description
Change in the number of glaucoma medications between baseline (pre-intervention) and the last follow-up visit
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muneera AlFutais
Phone
+966114849700
Ext
1374
Email
mfutais@kkesh.med.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adi Al Owaifeer, MBBS
Organizational Affiliation
King Khaled Eye Specialist Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ibrahim Alobaida, MD
Organizational Affiliation
King Khaled Eye Specialist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Khaled Eye Specialist Hospital
City
Riyadh
ZIP/Postal Code
11462
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muneera AlFutais
Phone
+966114849700
Ext
1374
Email
mfutais@kkesh.med.sa
First Name & Middle Initial & Last Name & Degree
Adi Al Owaifeer, MBBS
First Name & Middle Initial & Last Name & Degree
Ibrahim Alobaida, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Phaco-ECP vs Phaco Alone in Primary Angle Closure

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