The Effect of Phacoemulsification on Intraocular Pressure... | NCT06252246

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Sep 30, 2022Actual

Completion Date

Sep 30, 2022Actual

First Submitted Date

Jan 20, 2024

First Submission Date that Met QC Criteria

Feb 7, 2024

First Posted Date

Feb 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2024

Last Update Posted Date

Feb 9, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thetthar Kanthar, Head of Ophthalmology, Ophthalmological department, Phanatnikhom HospitalPrincipal Investigator

Lead Sponsor

Phanatnikhom HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

BACKGROUND: Primary angle closure glaucoma (PACG) is one of a leading cause of blindness worldwide including Thailand. This problem impact to the overall health of people and health care system. Treatment guidelines of each stage is differenced. Therefore, factors that affect to treatment should be explored to plan for taking care patients in the future.

OBJECTIVES: The study aimed to examine the effects of cataract surgery by phaco- emulsification on intraocular pressure and to determine the factors associated with intraocular pressure among primary angle closure glaucoma patients.

Detailed Description

METHODS: A retrospective descriptive study was conducted in 121 patients with primary angle closure glaucoma who underwent phacoemulsification between October 1st 2017 and September 30th 2022. The preoperative and postoperative record form were used as the research instrument. Visual acuity, intraocular pressure, the number of glaucoma medications and ocular biometric parameters were collected. The descriptive statistics, Paired sample t-test, Repeated measures ANOVA and Multiple linear regression were used to analyze the outcomes. A p-value < 0.05 was considered statistically significant.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

121Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phacoemulsification machine	Device	type of phacoemulsification machine is different

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intraocular pressure	effects of cataract surgery by phacoemulsification on intraocular pressure and to determine the factors associated with intraocular pressure among primary angle closure glaucoma patients. Units of measure assessment intraocular pressure by non contact tonometry(intraocular pressure in millimeters of Mercury) at one week, one month, three months and six months postoperatively	six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age more 18 years old and not complication of cataract surgey

Exclusion Criteria:

other eye diseases affect to visual defect
previous ocular surgery
complication of cataract surgery
data record incomplete

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary angle closure glaucoma (PACG) is one of a leading cause of blindness worldwide including Thailand. This problem impact to the overall health of people and health care system. Treatment guidelines of each stage is differenced. Therefore, factors that affect to treatment should be explored to plan for taking care patients in the future

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Phanatnikhom hospital		Chon Buri	Changwat Chon Buri	20140	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases