Corneal Densitometry in Acute Primary Angle Closure Glaucoma

NCT04254458 | Completed DMC

• 1 other identifier: E-18-1866
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Primary Angle-closure Glaucoma

Keywords

Cornea,; density,; laser peripheral iridotomy,; primary angle closure glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measurement of central corneal thickness by Pentacam HR-Scheimpflug corneal topography

  1 month

Study Arms (1)

PACG group

Cases who had first acute attack of primary angle closure glaucoma

Diagnostic Test: Corneal densitometry

Interventions

Corneal densitometry DIAGNOSTIC_TEST

Corneal density values were measured by densitometry software of Pentacam HR-Scheimpflug corneal topography

PACG group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients were Turkish Caucasians with with first attack of primary angle closure glaucoma

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ulucanlar Eye Training and Research Hospital: lead

Study Sites (1)

Ufuk Elgin

Ankara, Altindag, 06240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Corneal Diseases; Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

Eye Diseases; Glaucoma; Ocular Hypertension

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 5, 2020
• Study Start: March 22, 2018
• Primary Completion: August 20, 2019
• Study Completion: September 1, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)