Non-CenterNCT07038967
Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification
An observational study of Non-Center and Diabetic Macular Edema, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to evaluate the progression of non-center-involving diabetic macular edema in the early postoperative period following phacoemulsification. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Center, Diabetic Macular Edema, Phacoemulsification
- What is being tested?
- Coloured photography, Fluorescein angiography and Optical coherence tomography
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Jun 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: This prospective study will be conducted on 50 diabetic patients aged ≥18 years, both sexes, with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME).
Who may be able to join
- Age ≥18 years.
- Both sexes.
- Patients with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME).
Who cannot join
- Traumatic cataract.
- Severe Non-Proliferative/ Proliferative Diabetic Retinopathy.
- Marked Asymmetry of retinopathy between both eyes.
- Mature senile cataract or severe lens opacity.
- Potentiality to have Phacotrabeculectomy surgery.
- Complications during or after the surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11591
Hatem F Abd Elfatah, MD, 00201001859927, tito78@yahoo.com
Samah M Fawzy, MD
About this study
Official title: Assessment of Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification
This study aims to evaluate the progression of non-center-involving diabetic macular edema in the early postoperative period following phacoemulsification.
Read the detailed description
Diabetic patients have been reported to have a higher prevalence of cataract and develop it at an earlier age compared with nondiabetic individuals.
According to recent population-based studies, diabetic macular edema (DME) is the most common cause of vision loss, with the incidence of non-center-involving DME (NCIDME) being higher than that of center-involving DME (CIDME). The prevalence of NCIDME in an urban south Indian population is 10.8%.
- Conditions
- Non-Center, Diabetic Macular Edema, Phacoemulsification
- Being tested
- Coloured photography, Fluorescein angiography, Optical coherence tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloured photographyOther
Coloured photography will be performed preoperatively and at 3 and 6 months postoperatively.
Fluorescein angiographyOther
Fluorescein angiography will be performed preoperatively and at 3 and 6 months postoperatively. The following features will be recorded on each angiography:
Optical coherence tomographyOther
Optical coherence tomography (OCT) scanning will be performed using the optical coherence tomography scanner OCT (OPTOVUE OCT). OCT will be performed preoperatively and at 3 and 6 months postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME) Receives: Other: Coloured photography; Other: Fluorescein angiography; Other: Optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
Best Corrected Visual Acuity (BCVA) will be recorded.
Measured: 6 months post-procedure
Secondary outcomes (3)
Intra ocular pressure
Intra ocular pressure (IOP) will be recorded.
Measured: 6 months post-procedure
Central macular thickness (CMT)
Central macular thickness (CMT) will be recorded.
Measured: 6 months post-procedure
Frequency distribution of Fluorescein leakage
Frequency distribution of Fluorescein leakage will be recorded.
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start29 Jun 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-CenterStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatem Fawzy Abd Elfatah Abo saif, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038967
- Sponsor's protocol ID
- FMASU R127/2025
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification
- ClinicalTrials.gov ID
- NCT07038967
- Acronym / sponsor ID
- FMASU R127/2025
- Conditions
- Non-Center, Diabetic Macular Edema, Phacoemulsification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 29 Jun 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 26 Jun 2025 (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.
This study aims to evaluate the progression of non-center-involving diabetic macular edema in the early postoperative period following phacoemulsification.
Detailed description
Diabetic patients have been reported to have a higher prevalence of cataract and develop it at an earlier age compared with nondiabetic individuals.
According to recent population-based studies, diabetic macular edema (DME) is the most common cause of vision loss, with the incidence of non-center-involving DME (NCIDME) being higher than that of center-involving DME (CIDME). The prevalence of NCIDME in an urban south Indian population is 10.8%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Coloured photography, Other: Fluorescein angiography, Other: Optical coherence tomographyPatients with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective study will be conducted on 50 diabetic patients aged ≥18 years, both sexes, with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME).
Key inclusion criteria (3 listed)
- Age ≥18 years.
- Both sexes.
- Patients with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME).
Key exclusion criteria (6 listed)
- Traumatic cataract.
- Severe Non-Proliferative/ Proliferative Diabetic Retinopathy.
- Marked Asymmetry of retinopathy between both eyes.
- Mature senile cataract or severe lens opacity.
- Potentiality to have Phacotrabeculectomy surgery.
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 |
|---|---|---|
| Coloured photographyColoured photography will be performed preoperatively and at 3 and 6 months postoperatively. | Other | Study group |
| Fluorescein angiographyFluorescein angiography will be performed preoperatively and at 3 and 6 months postoperatively. The following features will be recorded on each angiography: | Other | Study group |
| Optical coherence tomographyOptical coherence tomography (OCT) scanning will be performed using the optical coherence tomography scanner OCT (OPTOVUE OCT). OCT will be performed preoperatively and at 3 and 6 months postoperatively. | Other | Study group |
Primary outcome
Best Corrected Visual Acuity
Time frame: 6 months post-procedure
Best Corrected Visual Acuity (BCVA) will be recorded.
3 secondary outcomes
Intra ocular pressure
Time frame: 6 months post-procedure
Central macular thickness (CMT)
Time frame: 6 months post-procedure
Frequency distribution of Fluorescein leakage
Time frame: 6 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
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 Non-Center and Diabetic Macular Edema, run by Ain Shams 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 6 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: looking for participants now, as of the sponsor's last update on 1 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hatem F Abd Elfatah, MD (00201001859927, tito78@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (time frame: 6 months post-procedure). 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 1 Jul 2025.