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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03889652
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Hebatalla Makled, Kasr El Aini Hospital

Study Description
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Brief Summary:
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)

Condition or disease Intervention/treatment
Cataract Primary Open-angle Glaucoma Diagnostic Test: Oct scans

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)

Study Design
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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison Between OCT Nerve Fiber Layer and Ganglion Cell Complex Parameters Following Cataract Extraction in Patients With or Without Primary Open Angle Glaucoma
Actual Study Start Date : October 20, 2018
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : March 20, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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

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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Intraocular pressure (IOP) change and central foveal thickness (CFT) change [ Time Frame: Six weeks after cataract surgery ]
    Assessment of the IOP and CFT change after cataract extraction


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with cataract without any other concomitant retinal, optic nerve head pathology other than POAG are included in the study and divided into two groups Group 1 patients with cataract only Group 2 patients with cataract and POAG who are planned for cataract surgery only and controlled on medical treatment
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889652


Locations
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Egypt
Kasr Al-Ainy teaching hospital
Cairo, Egypt, 11562
Sponsors and Collaborators
Kasr El Aini Hospital
More Information
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Responsible Party: Hebatalla Makled, Ophthalmology lecturer, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03889652    
Other Study ID Numbers: N-68-2018
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hebatalla Makled, Kasr El Aini Hospital:
Retinal nerve fiber layer (RNFL)
Ganglion cell complex (GCC)
Optical coherence tomography (OCT)
Primary open angle glaucoma (POAG)
Cataract
Additional relevant MeSH terms:
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Ganglion Cysts
Glaucoma
Cataract
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
 Lens Diseases
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases