Optical Coherence Tomography of Nerve Fiber Layer and Ganglion Cell Complex After Cataract Extraction

Overview

Optical coherence tomography (OCT) for retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) is done before and after cataract extraction in patients with or without primary open angle glaucoma (POAG)

Full Title of Study: “Comparison Between OCT Nerve Fiber Layer and Ganglion Cell Complex Parameters Following Cataract Extraction in Patients With or Without Primary Open Angle Glaucoma”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 30, 2019

Detailed Description

The investigator's study includes two groups of patients, each consists of 25 eyes, group 1 (cataract group)includes patients who are planned for cataract extraction without any other preexisting retinal or optic nerve pathology that may affect the RNFL thickness, while group 2 (combined cataract and glaucoma group) includes patients who are diagnosed with POAG controlled on medical treatment with cataract and planned for cataract extraction only. The OCT scans with complete ophthalmological examination are done before surgery and 6 weeks after uneventful cataract extraction (phacoemulsification with intraocular lens implantation)

Interventions

  • Diagnostic Test: Oct scans
    • Oct scans to assess thickness of RNFL and GCC before and after cataract extraction surgery in both groups

Arms, Groups and Cohorts

  • Cataract group
    • Group 1 includes patients who are planned for cataract extraction without any other preexisting retinal or optic nerve pathology that may affect the RNFL thickness. OCT (investigation) before and after cataract extraction
  • Combined cataract and glaucoma group
    • Group 2 includes patients who are diagnosed with POAG controlled on medical treatment and have cataract and planned for cataract extraction only OCT is done before and after cataract extraction

Clinical Trial Outcome Measures

Primary Measures

  • RNFL and GCC thickness
    • Time Frame: Oct scans before and 6 weeks after surgery
    • Assessment of RNFL and GCC thickness change after cataract extraction

Secondary Measures

  • Final best corrected visual acuity (BCVA)
    • Time Frame: Six weeks after cataract surgery
    • Assessment of the final BCVA recorded according to the Snellen chart and converted to logMAR for statistical analysis

Participating in This Clinical Trial

Inclusion Criteria

• patients with cataract without any other concomitant retinal, optic nerve head pathology other than POAG are included in the study and divided onto two groups Exclusion Criteria:

  • Patients having any retinal or optic nerve pathology that might have affected nerve fiber layer thickness other than POAG eg: high myopia – POAG patients who are planned for combined surgery – Refractive errors greater than spherical equivalent of 6 diopters (myopia or hypermetropia) – Dense cataract hindering OCT imaging – History of previous ocular surgery or trauma

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Kasr El Aini Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hebatalla Makled, Ophthalmology lecturer – Kasr El Aini Hospital

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