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

NCT ID: NCT03889652

Last Updated: 2019-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-20

Study Completion Date

2019-03-20

Brief Summary

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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

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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)

Conditions

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Cataract Primary Open-angle Glaucoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Oct scans

Intervention Type DIAGNOSTIC_TEST

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

Oct scans

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Oct scans

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hebatalla Makled

Ophthalmology lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasr Al-Ainy teaching hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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N-68-2018

Identifier Type: -

Identifier Source: org_study_id

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