NCT05289453

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2022

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

March 11, 2022

Last Update Submit

March 18, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    3 months follow-up

Study Arms (1)

study group

EXPERIMENTAL

patients wit acute congestive glaucoma and treated bt lens extraction by phacoemulsification after IOP control

Procedure: lens extraction by phacoemulsification

Interventions

lens extraction by phacoemulsification

study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with acute congestive glaucoma

You may not qualify if:

  • people under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hany Mahmoud

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 11, 2022

First Posted

March 21, 2022

Study Start

February 20, 2022

Primary Completion

June 20, 2022

Study Completion

June 20, 2022

Last Updated

March 21, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
after research completion

Locations