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

Sponsor
Kasr El Aini Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03889652
Collaborator
(none)
48
1
5
9.7

Study Details

Study Description

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 Phase
  • 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

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 :
Oct 20, 2018
Actual Primary Completion Date :
Jan 30, 2019
Actual Study Completion Date :
Mar 20, 2019

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. RNFL and GCC thickness [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) [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 [Six weeks after cataract surgery]

    Assessment of the IOP and CFT change after cataract extraction

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Kasr Al-Ainy teaching hospital Cairo Egypt 11562

Sponsors and Collaborators

  • Kasr El Aini Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hebatalla Makled, Ophthalmology lecturer, Kasr El Aini Hospital
ClinicalTrials.gov Identifier:
NCT03889652
Other Study ID Numbers:
  • N-68-2018
First Posted:
Mar 26, 2019
Last Update Posted:
Mar 27, 2019
Last Verified:
Mar 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hebatalla Makled, Ophthalmology lecturer, Kasr El Aini Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 27, 2019