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

March 25, 2019 updated by: Hebatalla Makled, Kasr El Aini Hospital

Comparison Between OCT Nerve Fiber Layer and Ganglion Cell Complex Parameters Following Cataract Extraction in Patients With or Without Primary Open Angle Glaucoma

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Kasr Al-Ainy teaching hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Six weeks after cataract surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Six weeks after cataract surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2018

Primary Completion (Actual)

January 30, 2019

Study Completion (Actual)

March 20, 2019

Study Registration Dates

First Submitted

March 22, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 26, 2019

Study Record Updates

Last Update Posted (Actual)

March 27, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-68-2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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