Posterior Pole Asymmetry Analysis (PPAA) for Early Glaucoma

Glaucoma Clinical Trial

— PPAA  

Official title:

Diagnostic Ability of Posterior Pole Asymmetry Analysis Parameters (PPAA) of Spectralis Optical Coherence Tomography (OCT) in Detecting Early Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02141594
• Other study ID #: OCT PPAA in early glaucoma
• Status: Completed
• Phase: N/A
• First received: May 14, 2014
• Last updated: May 16, 2014
• Start date: August 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Dr T V Patel Eye Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Spectrailis optical coherence tomography has come with a new posterior pole asymmetry analysis for glaucoma diagnosis. The aim of the investigators study was to assess its applicability in diagnosing early glaucoma patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 49 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age more than 18 years

• Best corrected visual acuity 20/40 or better

• Refractive error within ±5D sphere and ±3D cylinder

• Willingness to participate in the study

Exclusion Criteria:

• Media opacities preventing imaging

• Intraocular surgery within the last 6 months

• Any retinal or neurological disease other than glaucoma that could confound the results of visual field examination and OCT.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma

Locations

Country	Name	City	State
India	Dr TV Patel Eye Institute	Vadodara	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Dr T V Patel Eye Institute

Country where clinical trial is conducted

India, 

References & Publications (4)

Mori S, Hangai M, Sakamoto A, Yoshimura N. Spectral-domain optical coherence tomography measurement of macular volume for diagnosing glaucoma. J Glaucoma. 2010 Oct-Nov;19(8):528-34. doi: 10.1097/IJG.0b013e3181ca7acf. — View Citation

Nakatani Y, Higashide T, Ohkubo S, Takeda H, Sugiyama K. Evaluation of macular thickness and peripapillary retinal nerve fiber layer thickness for detection of early glaucoma using spectral domain optical coherence tomography. J Glaucoma. 2011 Apr-May;20( — View Citation

Rao HL, Babu JG, Addepalli UK, Senthil S, Garudadri CS. Retinal nerve fiber layer and macular inner retina measurements by spectral domain optical coherence tomograph in Indian eyes with early glaucoma. Eye (Lond). 2012 Jan;26(1):133-9. doi: 10.1038/eye.2 — View Citation

Seong M, Sung KR, Choi EH, Kang SY, Cho JW, Um TW, Kim YJ, Park SB, Hong HE, Kook MS. Macular and peripapillary retinal nerve fiber layer measurements by spectral domain optical coherence tomography in normal-tension glaucoma. Invest Ophthalmol Vis Sci. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under curve for all the diagnostic parameters of optical coherence tomography	This was a cross sectional study with one time measurement of the diagnostic parameters of the optical coherence tomography.	up to 32 weeks	No