Diabetic RetinopathyNCT03571139
Detecting the Influence of Cataract Surgery on the Development of Diabetic Retinopathy in Patients With Diabetes Mellitus Type 2 With and Without Diabetic Retinopathy Using OCT Angiography
An observational study of Diabetic Retinopathy, run by Cairo University at 1 site in Jordan.
Trial summary
Detecting the influence of cataract surgery on the development of diabetic retinopathy in patients with diabetes mellitus type 2 with and without diabetic retinopathy using OCT angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Phacoemulsification
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jun 2018to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diabetes mellitus type 2 with and without diabetic retinopathy (on biomicroscopy examination) who need cataract surgery.
Who may be able to join
- Patients with diabetes mellitus type 2 with and without diabetic retinopathy who needs cataract surgery.
- Patients who need cataract surgery without any intravitreal injections.
- Absence of any ocular disease other than diabetes mellitus.
- Cataract density allowing good visualization of the fundus by OCT angiography.
- Patients with uneventful cataract surgery with phacoemulsification.
Who cannot join
- Patients who fail to comply with the follow-up schedule.
- Very dense cataract not allowing good visualization of the fundus by OCT angiography.
- Patients with complicated cataract surgery with phacoemulsification.
- Patients who need cataract surgery with any intravitreal injection.
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
German Eye Center
Amman
Ibrahim Al-Nawaiseh, MD, 00962795667760, i-nawaiseh@hotmail.com
About this study
Official title: OCT Angiography Changes in Patients With Diabetes Mellitus Type 2 With and Without Diabetic Retinopathy Undergoing Phacoemulsification
Detecting the influence of cataract surgery on the development of diabetic retinopathy in patients with diabetes mellitus type 2 with and without diabetic retinopathy using OCT angiography.
Read the detailed description
Patients with diabetes mellitus type 2 with and without without diabetic retinopathy (on biomicroscopy examination) who need cataract surgery, will undergo OCT angiography examination prior to their cataract surgery. Average vessel density (%) in superficial capillary plexus, deep capillary plexus and choriocapillaris, parafoveal vessel density (%) in the superficial and deep plexuses, FAZ area (mm2) in the superficial capillary plexus, FAZ circularity, retinal thickness, microaneurysms and capillary non-perfusion will be taken into analysis.
Patients will be examined on the first day after the cataract surgery with phacoemulsification and in the bag posterior chamber lens implantation.
All patients will undergo OCT angiography examination four weeks after their cataract surgery.
- Conditions
- Diabetic Retinopathy
- Being tested
- Phacoemulsification
- Keywords
- OCT angiography, Diabetic retinopathy, Cataract surgery
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhacoemulsificationDevice
Cataract surgery and in the bag posterior chamber lens implantation
| Study group | Role | What they receive |
|---|---|---|
| Diabetics type 2 with and without diabetic retinopathy | Patients with diabetes mellitus type 2 with and without diabetic retinopathy who needs cataract surgery by phacoemulsification. All patients will undergo OCT angiography examination prior to their cataract surgery and 4 weeks after the cataract surgery. Receives: Device: Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detecting changes in the retinal vascular plexuses and choriocapillaris after cataract surgery in type 2 diabetes mellitus patients with and without diabetic retinopathy using OCT angiography.
Changes in the retinal vascular plexus, superficial and deep vessel density, foveal avascular zone area, circularity and any developing microaneurysms and areas of retinal ischemia will be measured to see the influence of cataract surgery on diabetic retinopathy.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start1 Jun 2018
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Tawfik Al Hanaineh, Cairo University
- Investigators
- Abeer T Al Hanaineh, MSc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571139
- Sponsor's protocol ID
- Abeer T Al Hanaineh
- Status last verified
- Jun 2018
- First submitted
- 15 Jun 2018
- Last updated
- 28 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCT Angiography Changes in Patients With Diabetes Mellitus Type 2 With and Without Diabetic Retinopathy Undergoing Phacoemulsification
- ClinicalTrials.gov ID
- NCT03571139
- Acronym / sponsor ID
- Abeer T Al Hanaineh
- Conditions
- Diabetic Retinopathy
- Keywords
- OCT angiography, Diabetic retinopathy, Cataract surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 27 Jun 2018 (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.
Detecting the influence of cataract surgery on the development of diabetic retinopathy in patients with diabetes mellitus type 2 with and without diabetic retinopathy using OCT angiography.
Detailed description
Patients with diabetes mellitus type 2 with and without without diabetic retinopathy (on biomicroscopy examination) who need cataract surgery, will undergo OCT angiography examination prior to their cataract surgery. Average vessel density (%) in superficial capillary plexus, deep capillary plexus and choriocapillaris, parafoveal vessel density (%) in the superficial and deep plexuses, FAZ area (mm2) in the superficial capillary plexus, FAZ circularity, retinal thickness, microaneurysms and capillary non-perfusion will be taken into analysis.
Patients will be examined on the first day after the cataract surgery with phacoemulsification and in the bag posterior chamber lens implantation.
All patients will undergo OCT angiography examination four weeks after their cataract surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetics type 2 with and without diabetic retinopathy | – | Device: PhacoemulsificationPatients with diabetes mellitus type 2 with and without diabetic retinopathy who needs cataract surgery by phacoemulsification. All patients will undergo OCT angiography examination prior to their cataract surgery and 4 weeks after the cataract surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetes mellitus type 2 with and without diabetic retinopathy (on biomicroscopy examination) who need cataract surgery.
Key inclusion criteria (5 listed)
- Patients with diabetes mellitus type 2 with and without diabetic retinopathy who needs cataract surgery.
- Patients who need cataract surgery without any intravitreal injections.
- Absence of any ocular disease other than diabetes mellitus.
- Cataract density allowing good visualization of the fundus by OCT angiography.
- Patients with uneventful cataract surgery with phacoemulsification.
Key exclusion criteria (4 listed)
- Patients who fail to comply with the follow-up schedule.
- Very dense cataract not allowing good visualization of the fundus by OCT angiography.
- Patients with complicated cataract surgery with phacoemulsification.
- Patients who need cataract surgery with any intravitreal injection.
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 |
|---|---|---|
| PhacoemulsificationCataract surgery and in the bag posterior chamber lens implantation | Device | Diabetics type 2 with and without diabetic retinopathy |
Primary outcome
Detecting changes in the retinal vascular plexuses and choriocapillaris after cataract surgery in type 2 diabetes mellitus patients with and without diabetic retinopathy using OCT angiography.
Time frame: 1 month
Changes in the retinal vascular plexus, superficial and deep vessel density, foveal avascular zone area, circularity and any developing microaneurysms and areas of retinal ischemia will be measured to see the influence of cataract surgery on diabetic retinopathy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
Abeer T Al Hanaineh, MSc principal investigator
Cairo University
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 Diabetic Retinopathy, run by Cairo University at 1 site in Jordan.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Jun 2018. 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 Jordan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abeer T Al Hanaineh, MSc (0096279184460, abeer_alhanaineh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detecting changes in the retinal vascular plexuses and choriocapillaris after cataract surgery in type 2 diabetes mellitus patients with and without diabetic retinopathy using OCT angiography. (time frame: 1 month). 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 28 Jun 2018.