DiabetesRGCCNCT02620644
Retinal Ganglion Cell Complex Changes by Optical Coherence Tomography in Diabetic Patients Without Retinopathy
A study testing OCT Retinal GCC in people with Diabetes, run by Cairo University at 1 site in Egypt.
Trial summary
Neuroretinal damage in diabetes produces functional abnormalities such as the loss of chromatic discrimination,contrast sensitivity and dark adaptation. These alterations can be detected by means of electrophysiological studies in diabetic patients with diabetes duration of less than two years, i.e. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes
- What is being tested?
- OCT Retinal GCC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2013to Dec 2014
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diabetic patients free from diabetic retinopathy will be group 1
- Non-diabetic subjects will be group 2.
Who cannot join
- Diabetic patients with diabetic retinopathy
- Patients having other ocular diseases as glaucoma or uveitis.
- Eye with history of previous ocular surgeries, trauma or intraocular injections or photocoagulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retinal Ganglion Cell Complex Changes Using Spectral Domain Optical Coherence Tomography in Diabetic Patients Without Retinopathy
Neuroretinal damage in diabetes produces functional abnormalities such as the loss of chromatic discrimination,contrast sensitivity and dark adaptation. These alterations can be detected by means of electrophysiological studies in diabetic patients with diabetes duration of less than two years, i.e. before microvascular lesions can be detected in ophthalmologic examination. Neurodegeneration seems to be a generalized process that occurs throughout the macula and is not confined to local abnormalities, in the cases with visible signs of retinopathy.
The debate is still open as to whether diabetic retinal neuropathy is the effect of vascular diabetic retinopathy or is primarily caused by direct neurologic damage from chronic hyperglycemia. The hypothesis that diabetes causes retinal neuro-pathy independent of retinopathy is intriguing and potentially links retinal neuropathy to other diabetic neuropathies.
Read more
Neuroretinal degeneration initiates and/or activates several metabolic and signalling pathways which participates in the microangiopathic process as well as in the disruption of the blood-retinal barrier which is a crucial element in the pathogenesis of diabetic retinopathy.
Retinal ganglion cells are the earliest cells affected and have the highest rate of apoptosis. However, an elevated rate of apoptosis has been also observed in the outer nuclear layer (photoreceptors) and in the retinal pigment epithelium (RPE). The use of spectral domain OCT (SD-OCT) makes it possible to measure the thickness of individual layers at higher resolution and indicates that the thinning of the inner retina in the macula is primarily due to loss of ganglion cells.
Read the detailed description
This was a prospective case-control study conducted from October 2012 to April 2013 at Kasr Al-ainy hospital- cairo university.
The subjects were divided into two groups; Group 1 consists of diabetic patients free from diabetic retinopathy (45 eyes). Group 2 consists of non-diabetic subjects, free from any ocular pathology(21 eyes).
All subjects were subjected to full medical and ophthalmological history, refraction, best corrected visual acuity (according to the snellen visual acuity chart and recorded in decimals), slit lamp examination (including measuring the intraocular pressure by Goldman applanation tonometer), dilated fundus examination by binocular indirect slit-lamp biomicroscopy and measuring of the retinal ganglion cell complex (GCC) thickness and the central foveal thickness (CFT) using the RTVue® SD-OCT (Optovue, Inc.) at the LASER unit, Kasr Al-ainy hospital.
In addition; diabetic patients were subjected to fundus fluorescein angiography to exclude diabetic changes that could be missed on clinical examination and measuring level of HbA1C in blood at kasr Al-ainy hospital chemical pathology unit.
Mapping of the GCC using the RTVue GCC scan consists of 15 vertical line scans covering a 7mm square region. The GCC scan centers at 1mm temporal to fovea center for better coverage of the temporal region.
The GCC thickness values are analyzed and compared to an extensive age-matched normative database. If the patient's values are outside the normal range, the measurement is color-coded appropriately. The Deviation Map shows the percent loss from normal as determined by the normative database. The significance Map shows regions where the change from normal reaches statistical significance. (Figure 1) Focal Loss Volume (FLV) and Global Loss Volume (GLV) are two parameters that provide quantitative measures for the amount of significant GCC loss. GLV measures the average amount of GCC loss over the entire GCC map. FLV measures the average amount of focal loss over the entire GCC map, it is the total sum of significant GCC loss (in volume) divided by the map area. As such it provides a percent of significant tissue loss for volume. FLV detects focal loss using a pattern deviation map to correct for overall absolute changes [5].
Statistical analysis included comparison of numerical variables between the study groups was done using Student t test for independent samples in normally distributed data and Mann Whitney U test for independent samples in non-normal data. For comparing categorical data, Chi square (2) test was performed. Exact test was used instead when the expected frequency is less than 5. Within group comparison between superior and inferior GCC was done using McNemar test. Agreement was tested using kappa statistic. Correlation between various variables was done using Spearman rank correlation equation. All statistical calculations were done using computer programs SPSS (Statistical Package for the Social Science; SPSS Inc., Chicago, IL, USA) version 15 for Microsoft Windows.
- Conditions
- Diabetes
- Being tested
- OCT Retinal GCC
- Keywords
- no retinopathy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT Retinal GCCDevice
measuring of the retinal ganglion cell complex (GCC) thickness and the central foveal thickness (CFT) using the RTVue® SD-OCT (Optovue, Inc.)
| Study group | Role | What they receive |
|---|---|---|
| G1 Diabetics with no retinpathy | Other | Group 1 consists of diabetic patients free from diabetic retinopathy (45 eyes). OCT retinal GCC measurements. Receives: Device: OCT Retinal GCC |
| G2 Non diabetics | Other | Group consists of non-diabetic subjects, free from any ocular pathology(21 eyes).OCT retinal GCC measurements. Receives: Device: OCT Retinal GCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal Ganglion Cell Complex in microns by Optical Coherence Tomography measurements
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Ahmed Macky, Cairo University
- Investigators
- Soheir Esmat, MD PhD, Study chair, Egypt:Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620644
- Sponsor's protocol ID
- Retinal GCC in Diabetics
- Acronym
- RGCC
- Status last verified
- Dec 2015
- First submitted
- 26 Nov 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Ganglion Cell Complex Changes Using Spectral Domain Optical Coherence Tomography in Diabetic Patients Without Retinopathy
- ClinicalTrials.gov ID
- NCT02620644
- Acronym / sponsor ID
- RGCC / Retinal GCC in Diabetics
- Conditions
- Diabetes
- Keywords
- no retinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Dec 2015 (estimated)
- 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.
Neuroretinal damage in diabetes produces functional abnormalities such as the loss of chromatic discrimination,contrast sensitivity and dark adaptation. These alterations can be detected by means of electrophysiological studies in diabetic patients with diabetes duration of less than two years, i.e. before microvascular lesions can be detected in ophthalmologic examination. Neurodegeneration seems to be a generalized process that occurs throughout the macula and is not confined to local abnormalities, in the cases with visible signs of retinopathy.
The debate is still open as to whether diabetic retinal neuropathy is the effect of vascular diabetic retinopathy or is primarily caused by direct neurologic damage from chronic hyperglycemia. The hypothesis that diabetes causes retinal neuro-pathy independent of retinopathy is intriguing and potentially links retinal neuropathy to other diabetic neuropathies.
Neuroretinal degeneration initiates and/or activates several metabolic and signalling pathways which participates in the microangiopathic process as well as in the disruption of the blood-retinal barrier which is a crucial element in the pathogenesis of diabetic retinopathy.
Retinal ganglion cells are the earliest cells affected and have the highest rate of apoptosis. However, an elevated rate of apoptosis has been also observed in the outer nuclear layer (photoreceptors) and in the retinal pigment epithelium (RPE). The use of spectral domain OCT (SD-OCT) makes it possible to measure the thickness of individual layers at higher resolution and indicates that the thinning of the inner retina in the macula is primarily due to loss of ganglion cells.
Detailed description
This was a prospective case-control study conducted from October 2012 to April 2013 at Kasr Al-ainy hospital- cairo university.
The subjects were divided into two groups; Group 1 consists of diabetic patients free from diabetic retinopathy (45 eyes). Group 2 consists of non-diabetic subjects, free from any ocular pathology(21 eyes).
All subjects were subjected to full medical and ophthalmological history, refraction, best corrected visual acuity (according to the snellen visual acuity chart and recorded in decimals), slit lamp examination (including measuring the intraocular pressure by Goldman applanation tonometer), dilated fundus examination by binocular indirect slit-lamp biomicroscopy and measuring of the retinal ganglion cell complex (GCC) thickness and the central foveal thickness (CFT) using the RTVue® SD-OCT (Optovue, Inc.) at the LASER unit, Kasr Al-ainy hospital.
In addition; diabetic patients were subjected to fundus fluorescein angiography to exclude diabetic changes that could be missed on clinical examination and measuring level of HbA1C in blood at kasr Al-ainy hospital chemical pathology unit.
Mapping of the GCC using the RTVue GCC scan consists of 15 vertical line scans covering a 7mm square region. The GCC scan centers at 1mm temporal to fovea center for better coverage of the temporal region.
The GCC thickness values are analyzed and compared to an extensive age-matched normative database. If the patient's values are outside the normal range, the measurement is color-coded appropriately. The Deviation Map shows the percent loss from normal as determined by the normative database. The significance Map shows regions where the change from normal reaches statistical significance. (Figure 1) Focal Loss Volume (FLV) and Global Loss Volume (GLV) are two parameters that provide quantitative measures for the amount of significant GCC loss. GLV measures the average amount of GCC loss over the entire GCC map. FLV measures the average amount of focal loss over the entire GCC map, it is the total sum of significant GCC loss (in volume) divided by the map area. As such it provides a percent of significant tissue loss for volume. FLV detects focal loss using a pattern deviation map to correct for overall absolute changes [5].
Statistical analysis included comparison of numerical variables between the study groups was done using Student t test for independent samples in normally distributed data and Mann Whitney U test for independent samples in non-normal data. For comparing categorical data, Chi square (2) test was performed. Exact test was used instead when the expected frequency is less than 5. Within group comparison between superior and inferior GCC was done using McNemar test. Agreement was tested using kappa statistic. Correlation between various variables was done using Spearman rank correlation equation. All statistical calculations were done using computer programs SPSS (Statistical Package for the Social Science; SPSS Inc., Chicago, IL, USA) version 15 for Microsoft Windows.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G1 Diabetics with no retinpathy | Other | Device: OCT Retinal GCCGroup 1 consists of diabetic patients free from diabetic retinopathy (45 eyes). OCT retinal GCC measurements. |
| G2 Non diabetics | Other | Device: OCT Retinal GCCGroup consists of non-diabetic subjects, free from any ocular pathology(21 eyes).OCT retinal GCC measurements. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetic patients free from diabetic retinopathy will be group 1
- Non-diabetic subjects will be group 2.
Key exclusion criteria (3 listed)
- Diabetic patients with diabetic retinopathy
- Patients having other ocular diseases as glaucoma or uveitis.
- Eye with history of previous ocular surgeries, trauma or intraocular injections or photocoagulation.
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 Retinal GCCmeasuring of the retinal ganglion cell complex (GCC) thickness and the central foveal thickness (CFT) using the RTVue® SD-OCT (Optovue, Inc.) | Device | G1 Diabetics with no retinpathy, G2 Non diabetics |
Primary outcome
Retinal Ganglion Cell Complex in microns by Optical Coherence Tomography measurements
Time frame: Baseline
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 3 Dec 2015.
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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.
Soheir Esmat, MD PhD study chair
Egypt:Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT Retinal GCC in people with Diabetes, run by Cairo University 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 2 inclusion and 3 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 3 Dec 2015. 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?
Retinal Ganglion Cell Complex in microns by Optical Coherence Tomography measurements (time frame: Baseline). 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 3 Dec 2015.