Corneal Densitometry in Acute Primary Angle Closure Glaucoma

Acute Primary Angle-closure Glaucoma Clinical Trial

Official title:

Laser Peripheral Iridotomy Induced Changes in Corneal Densitometry in Acute Primary Angle Closure Glaucoma Cases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04254458
• Other study ID #: E-18-1866
• Status: Completed
• Start date: March 22, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: January 2020
• Source: Ulucanlar Eye Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 1, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Primary Angle-closure Glaucoma
• Glaucoma
• Glaucoma, Angle-Closure

Intervention

Diagnostic Test:
• Corneal densitometry
Corneal density values were measured by densitometry software of Pentacam HR-Scheimpflug corneal topography

Locations

Country	Name	City	State
Turkey	Ufuk Elgin	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Ulucanlar Eye Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Secondary	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.	1 month