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

Completed

• Conditions: Primary Open-angle Glaucoma; Cataract
• Interventions: Diagnostic Test: Oct scans

• Registration Number: NCT03889652
• Lead Sponsor: Kasr El Aini Hospital

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)

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 Timeline

• Study Start: 2018-10-20
• Primary Completion: 2019-01-30
• Status Verified: 2019-03
• Study Completion: 2019-03-20
• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-25
• Last Update Submitted: 2019-03-25
• Study First Posted: 2019-03-26
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cataract group	Oct scans	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	Oct scans	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Kasr Al-Ainy teaching hospital; 🇪🇬 Cairo, Egypt