Structure Function Correlation in Primary Open Angle Glaucoma

NCT02028572 | Completed

• 1 other identifier: GLC-STR-FN
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Glaucoma is an optic neuropathy characterised by progressive degeneration of retinal ganglion cells and axons that leads to nerve fibre loss, optic disc cupping, and consecutive glaucomatous visual field defects. It is considered to be one of the major causes of blindness worldwide. It is a well accepted fact least 25 - 40% of retinal ganglion cells need to be lost before statistically detectable visual field defects appear on automated visual field testing, which is also consistent with post-mortem histologic findings in glaucomatous eyes. Since the damage associated with glaucoma is irreversible, and retinal nerve fibre layer loss is considered as an early sign of glaucomatous damage, its early detection and prevention is warranted. Retinal nerve fibre layer studies can be undertaken through non - invasive, reproducible technologies such as optical coherence tomography, scanning laser polarimetry etc. The purpose of the study is to evaluate the relationship between visual fields and retinal nerve fibre layer thickness as measured by Cirrus spectral domain optical coherence tomography with visual fields by Humphrey Field Analyser (HFA) in early and moderate primary open - angle glaucoma.

Conditions

Primary Open Angle Glaucoma

Keywords

Structure function correlation; Optical coherence tomography; Retinal Nerve fibre layer thickness; Visual fields; Primary open angle glaucoma

Outcome Measures

Primary Outcomes (1)

• Correlation between retinal nerve fibre layer thickness measured by optical coherence tomography and mean sensitivity, mean deviation as reported by visual fields.

  The subjects shall be studied over an avergae period of 4 weeks from the presentation for the purpose of optical coherence tomography and visual field studies.

Secondary Outcomes (1)

• Correlation between retinal nerve fibre layer thinning and scotomatous defects in visual fields in primary open angle glaucoma.

  The subjects shall be reviewed over an average period of 4 weeks to obtain the optical coherence tomography and visual field studies.

Study Arms (1)

Primary open angle glaucoma

Subjects diagnosed to have primary open angle glaucoma with intraocular pressure \> 21 mm Hg and characteristic glaucomatous damage to the optic nerve.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects presenting to the glaucoma clinic of a tertiary eye care hospital an diagnosed to have primary open angle glaucoma

You may qualify if:

• Subjects visiting a glaucoma clinic diagnosed with primary open - angle glaucoma.
• Subjects should have best corrected visual acuity not less than 6/18.
• Refractive spherical error within the range of -6.00 dioptres to + 3.00 dioptres and cylindrical error within +/- 2.5 dioptres.
• Visual fields examination of the subjects demonstrating field defects secondary to glaucomatous damage with mean deviation ranging from -2 to -10 decibels (db).
• The visual fields of the subjects should be within the reliability criteria (\<20% fixation losses, false positives and false negatives).
• The signal to noise ratio for a reliable Optical Coherence Tomograph - Retinal Nerve Fibre Layer scan shall not be less than 6.

You may not qualify if:

• History of (H/O) retinal disease or photocoagulation.
• H/O ocular trauma or surgery except an uncomplicated cataract surgery.
• H/O other optic nerve disease except glaucoma
• H/O amblyopia
• Neurological disease which can affect visual fields.
• Visually significant cataracts (Posterior Subcapsular Cataracts, \> N.S Grade II).

Sponsors & Collaborators

• Vasan Eye Care Hospital: lead

Study Sites (1)

Vasan Eye Care Hospital

Chennai, Tamil Nadu, 600015, India

Location

Related Publications (3)

• Hood DC, Kardon RH. A framework for comparing structural and functional measures of glaucomatous damage. Prog Retin Eye Res. 2007 Nov;26(6):688-710. doi: 10.1016/j.preteyeres.2007.08.001. Epub 2007 Aug 21.

  PMID: 17889587 BACKGROUND

• El Beltagi TA, Bowd C, Boden C, Amini P, Sample PA, Zangwill LM, Weinreb RN. Retinal nerve fiber layer thickness measured with optical coherence tomography is related to visual function in glaucomatous eyes. Ophthalmology. 2003 Nov;110(11):2185-91. doi: 10.1016/S0161-6420(03)00860-1.

  PMID: 14597528 BACKGROUND

• Ajtony C, Balla Z, Somoskeoy S, Kovacs B. Relationship between visual field sensitivity and retinal nerve fiber layer thickness as measured by optical coherence tomography. Invest Ophthalmol Vis Sci. 2007 Jan;48(1):258-63. doi: 10.1167/iovs.06-0410.

  PMID: 17197541 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Dr.Venkatesh Sugantharaj, MS, DNB

  Vasan Eye Care Hospital

  STUDY DIRECTOR

• Dr.RAMESH HARIHARAN, MBBS,DNB

  Vasan Eye Care Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Ophthalmologist

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: January 7, 2014
• Study Start: February 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

IN (1)