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OpenTrials
Completed

NCT Number: NCT03889652

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

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)

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Key information

Conditions

Cataract Eye Diseases Glaucoma Glaucoma, Open-Angle Lens Diseases Ocular Hypertension Primary Open-Angle Glaucoma

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kasr Al-Ainy teaching hospital

Cairo, 11562, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oct scans

Diagnostic Test

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 26, 2019
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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