Phacoemulsification in Acute Congestive Glaucoma
Primary Purpose
Glaucoma
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lens extraction by phacoemulsification
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- patients with acute congestive glaucoma
Exclusion Criteria:
- people under 18 years
Sites / Locations
- Hany MahmoudRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
study group
Arm Description
patients wit acute congestive glaucoma and treated bt lens extraction by phacoemulsification after IOP control
Outcomes
Primary Outcome Measures
iop control
iop will be assessed by applination tonometry and the values will be recorded, the success is defined by normal iop values during follow up period (3 months)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05289453
Brief Title
Phacoemulsification in Acute Congestive Glaucoma
Official Title
Phacoemulsification in Acute Congestive Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
June 20, 2022 (Anticipated)
Study Completion Date
June 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hany Mahmoud
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
Acute primary angle closure (APAC) is usually caused by an abrupt closure of the trabecular meshwork in the anterior chamber angle that leads to a sudden rise in intraocular pressure (IOP). APAC is a subgroup of angle closure disease characterised by a sudden onset of headache, blurred vision, seeing halos around lights, corneal oedema, mid-dilated pupil, eye pain and redness. Asian also has a much higher incident rate of APAC compare to the Caucasian population - with the crude incidence rate of 12.2 and 10.4 per 100,000 people per year in the above 30-year-old population of Singapore and Hong Kong, respectively . This is higher than the average incidence rate of 3.9-4.1 cases per 100,000 people per year in the European regions .
In APAC, both LPI and primary lens extraction by phacoemulsification and intraocular lens implant (phaco/IOL) were demonstrated to be effective to control IOP elevation. The latter has been shown to be the more effective treatment than LPI for IOP reduction at the early and mid-term IOP control. Together with the advancement of phaco/IOL technique, primary lens extraction is the more popular choice of treatment nowadays. However, operating on an eye with early aborted APAC is technically challenging and may increase the risk of complications because of the presence of corneal oedema, inflammation, shallow anterior chamber, floppy iris and unstable lens. Furthermore, "the best time window" for performing lens extraction after an APAC attack remains uncertain. The long-term results (e.g. more than 5 years) of early lens extraction compared to the conventional LPI are also unknown. In this study, we summarise the approach of treating APAC at the initial acute stage and review the studies that consider IOP control in the mid and long term. We would also touch on the role of goniosynechialysis, trabeculectomy and endoscopic cyclophotocoagulation in treating APAC, as well as considering the economic aspect of treatment.
Aim of the study: to evaluate the safety and efficacy of phacoemulsificatiojn in cases of acute congestive glaucoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
patients wit acute congestive glaucoma and treated bt lens extraction by phacoemulsification after IOP control
Intervention Type
Procedure
Intervention Name(s)
lens extraction by phacoemulsification
Intervention Description
lens extraction by phacoemulsification
Primary Outcome Measure Information:
Title
iop control
Description
iop will be assessed by applination tonometry and the values will be recorded, the success is defined by normal iop values during follow up period (3 months)
Time Frame
3 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with acute congestive glaucoma
Exclusion Criteria:
people under 18 years
Facility Information:
Facility Name
Hany Mahmoud
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany Mahmoud, MD
Phone
00201024368111
Email
drhanymahmoud@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
after research completion
Learn more about this trial
Phacoemulsification in Acute Congestive Glaucoma
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