Corneal Densitometry in Acute Primary Angle Closure Glaucoma

Completed

• Conditions: Acute Primary Angle-closure Glaucoma
• Interventions: Diagnostic Test: Corneal densitometry

• Registration Number: NCT04254458
• Lead Sponsor: Ulucanlar Eye Training and Research Hospital

Brief 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.

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 Timeline

• Study Start: 2018-03-22
• Primary Completion: 2019-08-20
• Study Completion: 2019-09-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-02-03
• Last Update Submitted: 2020-02-03
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PACG group	Corneal densitometry	Cases who had first acute attack of primary angle closure glaucoma

Primary Outcome Measures

Name	Time	Method
Measurement of corneal density by Pentacam HR-Scheimpflug corneal topography	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.

Secondary Outcome Measures

Name	Time	Method
Measurement of central corneal thickness by Pentacam HR-Scheimpflug corneal topography	1 month	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.

Trial Locations

Locations (1)

Ufuk Elgin; 🇹🇷 Ankara, Altindag, Turkey