Diabetic RetinopathyNCT04594603
Changes of Macular Vasculature After Uncomplicated Phacoemulsification Surgery Using Optical Coherence Tomography Angiography
An observational study of Diabetic Retinopathy, run by Tanta University at 1 site in Egypt.
Trial summary
To record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using OCTA, a comparative study between healthy and diabetic patients Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Phacoemulsification for cataract
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Apr 2021to 30 Dec 2024
- How long will I take part?
- 1 Week
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This will be a prospective study of 30 patients with senile or complicated cataract scheduled to do phacoemulsification surgery in Tanta University Hospital
Who may be able to join
- - Presence of a nuclear, cortical cataract or complicated cataract due to diabetic mellitus
- Intraocular pressure (IOP) of 21 mm Hg or lower
- Axial length (AL) between 20.0 mm and 25.0 mm.
Who cannot join
- Eyes with an AL longer than 25.0 mm or shorter than 20.0 mm,
- IOP higher than 21 mm Hg,
- History of ocular trauma or intraocular surgery, or any abnormal intraocular findings
- Poor OCT-A images because of severe cataracts or unstable fixation
- Any signs of intraoperative or postoperative complications
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospital
Tanta, El-Garbeia, 31515
Dina Tadros, MD
About this study
To record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using OCTA, a comparative study between healthy and diabetic patients
Read the detailed description
A prospective study of 30 patients with senile or complicated cataract scheduled to do phacoemulsification surgery in Tanta University Hospital
Two groups will be divided:
- Group (1): Cataract will no diabetic retinopathy
- Group (2): Cataract associated with diabetic retinopathy.
All patients will be subject to Full ophthalmologic examination before the surgery. Imaging will include OCTA. OCTA will be performed using cirrus OCT (Zeiss, Inc., USA). High-quality 6 x 6 mm OCTA macular scans and 3 × 3-mm papillary scan with strong signal-noise ratio with adequate centration on the fovea and optic nerve head respectively will be selected.
Segmentation will be used to evaluate superficial and deep capillary retinal plexus projections in addition to the choriocapillaries. If errors in segmentation were detected, manual correction would be performed. The superficial retinal capillary plexus (SCP) will be delineated with an inner boundary at the internal limiting membrane (ILM) and an outer boundary 10 µm inside the inner plexiform layer (IPL). The deep retinal capillary plexus (DCP) will be segmented with an inner boundary 10 µm inside the IPL and an outer boundary at 10 µm beneath the outer plexiform layer (OPL).
The vessel density metric from enface OCT angiogram will be used as an indicator of macular retinal and papillary perfusion. Vessel density (VD) analysis computes the percentage of area occupied by OCTA detected vasculature in a measured area. Choriocapillaries flow voids will be computed to assess choriocapillaries circulation.
The measurements of the OCTA, axial length, intraocular pressure will be obtained before the phacoemulsification surgery. Optical coherence tomography and IOP measurements will also be obtained 1 week after surgery.
- Conditions
- Diabetic Retinopathy
- Being tested
- Phacoemulsification for cataract
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification for cataractOther
Phacoemulsification for removal of cataract
| Study group | Role | What they receive |
|---|---|---|
| Group(1): Cataract with no diabetic retinopathy | Not described Receives: Other: Phacoemulsification for cataract | |
| Group (2): Cataract associated with diabetic retinopathy | Not described Receives: Other: Phacoemulsification for cataract |
What is being measured
The primary outcome is the main question the study is designed to answer.
To record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using OCTA
Measured: 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start13 Apr 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Tadros, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594603
- Sponsor's protocol ID
- 34082/9/20
- Status last verified
- Dec 2023
- First submitted
- 13 Oct 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Mirshahi A, Hohn F, Lorenz K, Hattenbach LO. Incidence of posterior vitreous detachment after cataract surgery. J Cataract Refract Surg. 2009 Jun;35(6):987-91. doi: 10.1016/j.jcrs.2009.02.016.
PubMed 19465281Ripandelli G, Coppe AM, Parisi V, Olzi D, Scassa C, Chiaravalloti A, Stirpe M. Posterior vitreous detachment and retinal detachment after cataract surgery. Ophthalmology. 2007 Apr;114(4):692-7. doi: 10.1016/j.ophtha.2006.08.045. Epub 2007 Jan 17.
PubMed 17208303Rossetti L, Autelitano A. Cystoid macular edema following cataract surgery. Curr Opin Ophthalmol. 2000 Feb;11(1):65-72. doi: 10.1097/00055735-200002000-00010.
PubMed 10724830Flach AJ. The incidence, pathogenesis and treatment of cystoid macular edema following cataract surgery. Trans Am Ophthalmol Soc. 1998;96:557-634. No abstract available.
PubMed 10360304Kim SJ, Equi R, Bressler NM. Analysis of macular edema after cataract surgery in patients with diabetes using optical coherence tomography. Ophthalmology. 2007 May;114(5):881-9. doi: 10.1016/j.ophtha.2006.08.053. Epub 2007 Feb 1.
PubMed 17275910Or C, Sabrosa AS, Sorour O, Arya M, Waheed N. Use of OCTA, FA, and Ultra-Widefield Imaging in Quantifying Retinal Ischemia: A Review. Asia Pac J Ophthalmol (Phila). 2018 Jan-Feb;7(1):46-51. doi: 10.22608/APO.201812. Epub 2018 Feb 13.
PubMed 29436208Sorour OA, Sabrosa AS, Yasin Alibhai A, Arya M, Ishibazawa A, Witkin AJ, Baumal CR, Duker JS, Waheed NK. Optical coherence tomography angiography analysis of macular vessel density before and after anti-VEGF therapy in eyes with diabetic retinopathy. Int Ophthalmol. 2019 Oct;39(10):2361-2371. doi: 10.1007/s10792-019-01076-x. Epub 2019 May 22.
PubMed 31119505
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Macular Vasculature After Uncomplicated Phacoemulsification Surgery Using Optical Coherence Tomography Angiography
- ClinicalTrials.gov ID
- NCT04594603
- Acronym / sponsor ID
- 34082/9/20
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 20 Oct 2020 (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.
To record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using OCTA, a comparative study between healthy and diabetic patients
Detailed description
A prospective study of 30 patients with senile or complicated cataract scheduled to do phacoemulsification surgery in Tanta University Hospital
Two groups will be divided:
- Group (1): Cataract will no diabetic retinopathy
- Group (2): Cataract associated with diabetic retinopathy.
All patients will be subject to Full ophthalmologic examination before the surgery. Imaging will include OCTA. OCTA will be performed using cirrus OCT (Zeiss, Inc., USA). High-quality 6 x 6 mm OCTA macular scans and 3 × 3-mm papillary scan with strong signal-noise ratio with adequate centration on the fovea and optic nerve head respectively will be selected.
Segmentation will be used to evaluate superficial and deep capillary retinal plexus projections in addition to the choriocapillaries. If errors in segmentation were detected, manual correction would be performed. The superficial retinal capillary plexus (SCP) will be delineated with an inner boundary at the internal limiting membrane (ILM) and an outer boundary 10 µm inside the inner plexiform layer (IPL). The deep retinal capillary plexus (DCP) will be segmented with an inner boundary 10 µm inside the IPL and an outer boundary at 10 µm beneath the outer plexiform layer (OPL).
The vessel density metric from enface OCT angiogram will be used as an indicator of macular retinal and papillary perfusion. Vessel density (VD) analysis computes the percentage of area occupied by OCTA detected vasculature in a measured area. Choriocapillaries flow voids will be computed to assess choriocapillaries circulation.
The measurements of the OCTA, axial length, intraocular pressure will be obtained before the phacoemulsification surgery. Optical coherence tomography and IOP measurements will also be obtained 1 week after surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group(1): Cataract with no diabetic retinopathy | – | Other: Phacoemulsification for cataract |
| Group (2): Cataract associated with diabetic retinopathy | – | Other: Phacoemulsification for cataract |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This will be a prospective study of 30 patients with senile or complicated cataract scheduled to do phacoemulsification surgery in Tanta University Hospital
Key inclusion criteria (3 listed)
- - Presence of a nuclear, cortical cataract or complicated cataract due to diabetic mellitus
- Intraocular pressure (IOP) of 21 mm Hg or lower
- Axial length (AL) between 20.0 mm and 25.0 mm.
Key exclusion criteria (5 listed)
- Eyes with an AL longer than 25.0 mm or shorter than 20.0 mm,
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 |
|---|---|---|
| Phacoemulsification for cataractPhacoemulsification for removal of cataract | Other | Group (2): Cataract associated with diabetic retinopathy, Group(1): Cataract with no diabetic retinopathy |
Primary outcome
To record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using OCTA
Time frame: 1 week after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Results publication: PubMed 19465281Mirshahi A, Hohn F, Lorenz K, Hattenbach LO. Incidence of posterior vitreous detachment after cataract surgery. J Cataract Refract Surg. 2009 Jun;35(6):987-91. doi: 10.1016/j.jcrs.2009.02.016.
- Results publication: PubMed 17208303Ripandelli G, Coppe AM, Parisi V, Olzi D, Scassa C, Chiaravalloti A, Stirpe M. Posterior vitreous detachment and retinal detachment after cataract surgery. Ophthalmology. 2007 Apr;114(4):692-7. doi: 10.1016/j.ophtha.2006.08.045. Epub 2007 Jan 17.
- Results publication: PubMed 10724830Rossetti L, Autelitano A. Cystoid macular edema following cataract surgery. Curr Opin Ophthalmol. 2000 Feb;11(1):65-72. doi: 10.1097/00055735-200002000-00010.
- Results publication: PubMed 10360304Flach AJ. The incidence, pathogenesis and treatment of cystoid macular edema following cataract surgery. Trans Am Ophthalmol Soc. 1998;96:557-634. No abstract available.
- Results publication: PubMed 17275910Kim SJ, Equi R, Bressler NM. Analysis of macular edema after cataract surgery in patients with diabetes using optical coherence tomography. Ophthalmology. 2007 May;114(5):881-9. doi: 10.1016/j.ophtha.2006.08.053. Epub 2007 Feb 1.
- Results publication: PubMed 29436208Or C, Sabrosa AS, Sorour O, Arya M, Waheed N. Use of OCTA, FA, and Ultra-Widefield Imaging in Quantifying Retinal Ischemia: A Review. Asia Pac J Ophthalmol (Phila). 2018 Jan-Feb;7(1):46-51. doi: 10.22608/APO.201812. Epub 2018 Feb 13.
- Results publication: PubMed 31119505Sorour OA, Sabrosa AS, Yasin Alibhai A, Arya M, Ishibazawa A, Witkin AJ, Baumal CR, Duker JS, Waheed NK. Optical coherence tomography angiography analysis of macular vessel density before and after anti-VEGF therapy in eyes with diabetic retinopathy. Int Ophthalmol. 2019 Oct;39(10):2361-2371. doi: 10.1007/s10792-019-01076-x. Epub 2019 May 22.
- Individual participant dataSharing planned: Yes
Related trials for Diabetic Retinopathy
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
Recruiting
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists
Proliferative Diabetic Retinopathy (PDR)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
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.
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 Tanta 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 3 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: status not confirmed, as of the sponsor's last update on 5 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina SM Tadros, MD (00201224093354, dinasabry@rocketmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using OCTA (time frame: 1 week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04594603, which also lists 7 linked publications.
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 5 Dec 2023.