Acute Primary Angle-closure GlaucomaNCT04254458
Corneal Densitometry in Acute Primary Angle Closure Glaucoma
An observational study of Acute Primary Angle-closure Glaucoma, run by Ulucanlar Eye Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Purpose: Our purpose was to investigate the laser peripheral iridotomy (LPI) induced changes in corneal densitometry in acute primary angle closure glaucoma (PACG) cases during the post-laser 1 month period. Material and methods: This prospective study included 21 eyes of 21 cases with first acute attack of PACG. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Acute Primary Angle-closure Glaucoma
- What is being tested?
- Corneal densitometry
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Mar 2018to 1 Sep 2019
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients were Turkish Caucasians with with first attack of primary angle closure glaucoma
Who may be able to join
- Acute primary angle closure glaucoma cases with first attack
- high IOP (>40 mmHg)
- corneal edema
- red eye
- mid-dilated pupil
- presence of the symptoms like blurred vision, halos, ocular pain, headache, nausea and vomiting
Who cannot join
- The cases who had histories of any types of glaucoma or increased IOP before
- any corneal diseases like keratokonus
- corneal opacity
- dry eye or any ocular surface diseases
- ocular surgery or laser treatment
- trauma
- uveitis or other inflammation and contact lens use and diabetic cases were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laser Peripheral Iridotomy Induced Changes in Corneal Densitometry in Acute Primary Angle Closure Glaucoma Cases
Purpose: Our purpose was to investigate the laser peripheral iridotomy (LPI) induced changes in corneal densitometry in acute primary angle closure glaucoma (PACG) cases during the post-laser 1 month period.
Material and methods: This prospective study included 21 eyes of 21 cases with first acute attack of PACG. All the eyes underwent LPI with neodymium: yttrium-aluminum-garnet (Nd: YAG) laser after the intraocular pressure (IOP) decreased to normal levels with maximal systemic and topical anti-glaucoma treatment and complete regression of clinically significant corneal edema. Central corneal thickness (CCT) and corneal density values were measured by densitometry software of Pentacam HR-Scheimpflug corneal topography over a 12-mm diameter of the cornea just before LPI and at the first week and the first month after LPI. Kolmogorov smirnov and paired-t tests were used for statistical analysis.
Read the detailed description
This prospective study included 21 eyes of 21 cases with first acute attack of PACG who had applied to emergency department of Ulucanlar Eye Research Hospital between March 2018 and January 2019. All the eyes underwent LPI with neodymium: yttrium-aluminum-garnet (Nd: YAG) laser after the IOP decreased to normal levels with maximal systemic and topical anti-glaucoma treatment and complete regression of clinically significant corneal edema.
During the acute attack ocular examination was performed at the emergency department including best-corrected visual acuity (BCVA) with Snellen charts, slit-lamb examination, fundus examination by +90 D lens, IOP measurements with Goldmann applanation tonometry, gonioscopy of the fellow eye with Goldmann three-mirror lens. Gonioscopy and fundus examinations were performed for the eyes with acute PACG after the regression of corneal edema.
All the cases had intravenous infusion of mannitol 20% (250-300 cc) at the emergency department. Oral acetazolamide 250 mg (3 times daily), oral potassium supplement, topical fixed-combination of beta-blocker and carbonic anhydrase inhibitors (twice daily) and brimonidine (twice daily). LPI procedures were performed within the first day of the attack (after 12-24 hours) by the same experienced physician (OA) with neodymium: yttrium-aluminum-garnet (Nd: YAG) laser under topical anesthesia with proparacain %0.5. Superior-nasal position (1 or 11 o'clock) was focused and 1 or more shots were performed (1-3 pulses per shot with 3-8 mJ energy).
Central corneal thickness (CCT) and CD values were measured by densitometry software of Pentacam HR-Scheimpflug corneal topography just before LPI and at the first week and the first month after LPI. All the measurements were performed by the same experienced clinician between 9 am and 2 pm under standard dim-light conditions without pupil dilatation.
- Conditions
- Acute Primary Angle-closure Glaucoma
- Being tested
- Corneal densitometry
- Keywords
- Cornea,, density,, laser peripheral iridotomy,, primary angle closure glaucoma
- Medical subject headings
- Corneal Diseases, Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal densitometryDiagnostic test
Corneal density values were measured by densitometry software of Pentacam HR-Scheimpflug corneal topography
| Study group | Role | What they receive |
|---|---|---|
| PACG group | Cases who had first acute attack of primary angle closure glaucoma Receives: Diagnostic Test: Corneal densitometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of corneal density by Pentacam HR-Scheimpflug corneal topography
The measurements were done between 9 am and 2 pm under standard dim-light conditions without pupil dilatation. The CD values of anterior layer (anterior 120 µm), central (between anterior layer and posterior 60 µm), posterior layer (posterior 60 µm) of 4 annular concentric zones as 0-2 mm zone, 2-6 mm zone, 6-10 mm zone and 10-12 mm zone were measured. The CD values were expressed in grayscale units (GSC) as 0 for maximum transparency and 100 for total corneal opacity. Measurement were done just before laser treatment and repeated at the first week and month.
Measured: 1 month
Secondary outcomes (1)
Measurement of central corneal thickness by Pentacam HR-Scheimpflug corneal topography
The measurements were done between 9 am and 2 pm under standard dim-light conditions without pupil dilatation. The central corneal thickness measurements just before laser treatment and at the first week and the first month.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start22 Mar 2018
- Primary completion20 Aug 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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-control
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulucanlar Eye Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ufuk Elgin, Ulucanlar Eye Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254458
- Sponsor's protocol ID
- E-18-1866
- Status last verified
- Jan 2020
- First submitted
- 29 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Peripheral Iridotomy Induced Changes in Corneal Densitometry in Acute Primary Angle Closure Glaucoma Cases
- ClinicalTrials.gov ID
- NCT04254458
- Acronym / sponsor ID
- E-18-1866
- Conditions
- Acute Primary Angle-closure Glaucoma
- Keywords
- Cornea,, density,, laser peripheral iridotomy,, primary angle closure glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ulucanlar Eye Training and Research HospitalUniversity, hospital or other
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 5 Feb 2020 (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.
Purpose: Our purpose was to investigate the laser peripheral iridotomy (LPI) induced changes in corneal densitometry in acute primary angle closure glaucoma (PACG) cases during the post-laser 1 month period.
Material and methods: This prospective study included 21 eyes of 21 cases with first acute attack of PACG. All the eyes underwent LPI with neodymium: yttrium-aluminum-garnet (Nd: YAG) laser after the intraocular pressure (IOP) decreased to normal levels with maximal systemic and topical anti-glaucoma treatment and complete regression of clinically significant corneal edema. Central corneal thickness (CCT) and corneal density values were measured by densitometry software of Pentacam HR-Scheimpflug corneal topography over a 12-mm diameter of the cornea just before LPI and at the first week and the first month after LPI. Kolmogorov smirnov and paired-t tests were used for statistical analysis.
Detailed description
This prospective study included 21 eyes of 21 cases with first acute attack of PACG who had applied to emergency department of Ulucanlar Eye Research Hospital between March 2018 and January 2019. All the eyes underwent LPI with neodymium: yttrium-aluminum-garnet (Nd: YAG) laser after the IOP decreased to normal levels with maximal systemic and topical anti-glaucoma treatment and complete regression of clinically significant corneal edema.
During the acute attack ocular examination was performed at the emergency department including best-corrected visual acuity (BCVA) with Snellen charts, slit-lamb examination, fundus examination by +90 D lens, IOP measurements with Goldmann applanation tonometry, gonioscopy of the fellow eye with Goldmann three-mirror lens. Gonioscopy and fundus examinations were performed for the eyes with acute PACG after the regression of corneal edema.
All the cases had intravenous infusion of mannitol 20% (250-300 cc) at the emergency department. Oral acetazolamide 250 mg (3 times daily), oral potassium supplement, topical fixed-combination of beta-blocker and carbonic anhydrase inhibitors (twice daily) and brimonidine (twice daily). LPI procedures were performed within the first day of the attack (after 12-24 hours) by the same experienced physician (OA) with neodymium: yttrium-aluminum-garnet (Nd: YAG) laser under topical anesthesia with proparacain %0.5. Superior-nasal position (1 or 11 o'clock) was focused and 1 or more shots were performed (1-3 pulses per shot with 3-8 mJ energy).
Central corneal thickness (CCT) and CD values were measured by densitometry software of Pentacam HR-Scheimpflug corneal topography just before LPI and at the first week and the first month after LPI. All the measurements were performed by the same experienced clinician between 9 am and 2 pm under standard dim-light conditions without pupil dilatation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PACG group | – | Diagnostic Test: Corneal densitometryCases who had first acute attack of primary angle closure glaucoma |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients were Turkish Caucasians with with first attack of primary angle closure glaucoma
Key inclusion criteria (6 listed)
- Acute primary angle closure glaucoma cases with first attack
- high IOP (>40 mmHg)
- corneal edema
- red eye
- mid-dilated pupil
Key exclusion criteria (7 listed)
- The cases who had histories of any types of glaucoma or increased IOP before
- any corneal diseases like keratokonus
- corneal opacity
- dry eye or any ocular surface diseases
- ocular surgery or laser treatment
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 |
|---|---|---|
| Corneal densitometryCorneal density values were measured by densitometry software of Pentacam HR-Scheimpflug corneal topography | Diagnostic test | PACG group |
Primary outcome
Measurement of corneal density by Pentacam HR-Scheimpflug corneal topography
Time frame: 1 month
The measurements were done between 9 am and 2 pm under standard dim-light conditions without pupil dilatation. The CD values of anterior layer (anterior 120 µm), central (between anterior layer and posterior 60 µm), posterior layer (posterior 60 µm) of 4 annular concentric zones as 0-2 mm zone, 2-6 mm zone, 6-10 mm zone and 10-12 mm zone were measured. The CD values were expressed in grayscale units (GSC) as 0 for maximum transparency and 100 for total corneal opacity. Measurement were done just before laser treatment and repeated at the first week and month.
1 secondary outcome
Measurement of central corneal thickness by Pentacam HR-Scheimpflug corneal topography
Time frame: 1 month
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 5 Feb 2020.
- Individual participant dataSharing planned: No
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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 Acute Primary Angle-closure Glaucoma, run by Ulucanlar Eye Training and Research Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 7 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 5 Feb 2020. 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 Turkey (Türkiye). 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?
Measurement of corneal density by Pentacam HR-Scheimpflug corneal topography (time frame: 1 month). 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 5 Feb 2020; AzTrials last refreshed its copy on 28 Oct 2026.