CataractNCT03889652
Optical Coherence Tomography of Nerve Fiber Layer and Ganglion Cell Complex After Cataract Extraction
An observational study of Cataract and Primary Open-angle Glaucoma, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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) Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Primary Open-angle Glaucoma
- What is being tested?
- Oct scans
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2018to 20 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read the 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)
- Conditions
- Cataract, Primary Open-angle Glaucoma
- Being tested
- Oct scans
- Keywords
- Retinal nerve fiber layer (RNFL), Ganglion cell complex (GCC), Optical coherence tomography (OCT), Primary open angle glaucoma (POAG), Cataract
- Medical subject headings
- Cataract, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oct scansDiagnostic test
Oct scans to assess thickness of RNFL and GCC before and after cataract extraction surgery in both groups
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Oct scans | |
| 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 Receives: Diagnostic Test: Oct scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
RNFL and GCC thickness
Assessment of RNFL and GCC thickness change after cataract extraction
Measured: Oct scans before and 6 weeks after surgery
Secondary outcomes (1)
Final best corrected visual acuity (BCVA)
Assessment of the final BCVA recorded according to the Snellen chart and converted to logMAR for statistical analysis
Measured: Six weeks after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start20 Oct 2018
- Primary completion30 Jan 2019
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebatalla Makled, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889652
- Sponsor's protocol ID
- N-68-2018
- Status last verified
- Mar 2019
- First submitted
- 22 Mar 2019
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03889652
- Acronym / sponsor ID
- N-68-2018
- Conditions
- Cataract, Primary Open-angle Glaucoma
- Keywords
- Retinal nerve fiber layer (RNFL), Ganglion cell complex (GCC), Optical coherence tomography (OCT), Primary open angle glaucoma (POAG), Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cataract group | – | Diagnostic Test: Oct scansGroup 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 | – | Diagnostic Test: Oct scansGroup 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oct scansOct scans to assess thickness of RNFL and GCC before and after cataract extraction surgery in both groups | Diagnostic test | Cataract group, Combined cataract and glaucoma group |
Primary outcome
RNFL and GCC thickness
Time frame: Oct scans before and 6 weeks after surgery
Assessment of RNFL and GCC thickness change after cataract extraction
1 secondary outcome
Final best corrected visual acuity (BCVA)
Time frame: Six weeks after cataract surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Primary Open-angle Glaucoma, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RNFL and GCC thickness (time frame: Oct scans before and 6 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.