Primary Angle Closure GlaucomaNCT06252246
The Effect of Phacoemulsification on Intraocular Pressure in Primary Angle Closure Glaucoma (PACG) Patients At Phanat Nikhom Hospital, Chonburi Province
An observational study of Primary Angle Closure Glaucoma, run by Phanatnikhom Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Angle Closure Glaucoma
- What is being tested?
- Phacoemulsification machine
- Type of treatment
- Medical device
- How many people
- 121 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2017to 30 Sep 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older 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
Who may be able to join
- age more 18 years old and not complication of cataract surgey
Who cannot join
- other eye diseases affect to visual defect
- previous ocular surgery
- complication of cataract surgery
- data record incomplete
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
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.
- Conditions
- Primary Angle Closure Glaucoma
- Being tested
- Phacoemulsification machine
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification machineDevice
type of phacoemulsification machine is different
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Oct 2017
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Angle Closure GlaucomaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phanatnikhom Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Thetthar Kanthar, Phanatnikhom Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252246
- Sponsor's protocol ID
- 5100500081212
- Status last verified
- Feb 2024
- First submitted
- 20 Jan 2024
- Last updated
- 9 Feb 2024
- 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 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Phacoemulsification on Intraocular Pressure in Primary Angle Closure Glaucoma (PACG) Patients At Phanat Nikhom Hospital, Chonburi Province
- ClinicalTrials.gov ID
- NCT06252246
- Acronym / sponsor ID
- 5100500081212
- Conditions
- Primary Angle Closure Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Phanatnikhom HospitalOther government
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 9 Feb 2024 (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.
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
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older 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
Key inclusion criteria (1 listed)
- age more 18 years old and not complication of cataract surgey
Key exclusion criteria (4 listed)
- other eye diseases affect to visual defect
- previous ocular surgery
- complication of cataract surgery
- data record incomplete
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 |
|---|---|---|
| Phacoemulsification machinetype of phacoemulsification machine is different | Device | – |
Primary outcome
intraocular pressure
Time frame: six months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Angle Closure Glaucoma, run by Phanatnikhom Hospital at 1 site in Thailand.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 9 Feb 2024. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraocular pressure (time frame: six months). 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 9 Feb 2024.