NCT02141594

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2014

Completed
Last Updated

May 19, 2014

Status Verified

May 1, 2014

Enrollment Period

7 months

First QC Date

May 14, 2014

Last Update Submit

May 16, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Early glaucoma

The study group consisted of consecutive unilateral glaucoma patients, categorized as early stage by Hodapp-Anderson-Parrish classification.

Normal subjects

Normal control subjects had a normal ocular examination, Intraocular pressure (IOP) \<22 mmHg, no past history of high IOP, no family history of glaucoma, normal optic disc morphology and visual field in both eyes. One eye of control subject was randomly selected.

Eligibility Criteria

Age49 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive 80 eyes of 80 normal subjects and 76 eyes of 76 patients with early glaucoma were included for the study.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr TV Patel Eye Institute

Vadodara, Gujarat, 390001, India

Location

Related 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.

  • 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(4):252-9. doi: 10.1097/IJG.0b013e3181e079ed.

  • 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. 2010 Mar;51(3):1446-52. doi: 10.1167/iovs.09-4258. Epub 2009 Oct 15.

  • 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.2011.277. Epub 2011 Nov 11.

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Paaraj R Dave, MS

    Dr TV Patel Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 14, 2014

First Posted

May 19, 2014

Study Start

August 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 19, 2014

Record last verified: 2014-05

Locations