Non-Center Involving Diabetic Macular Edema Progression i... | NCT07038967

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 29, 2025Actual

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Jun 18, 2025

First Submission Date that Met QC Criteria

Jun 18, 2025

First Posted Date

Jun 26, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2025

Last Update Posted Date

Jul 1, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hatem Fawzy Abd Elfatah Abo saif, Lecturer of Ophthalmology, Faculty of Medicine, Ain Shams University, Cairo, Egypt., Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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%.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		Patients with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME)	Other: Coloured photography Other: Fluorescein angiography Other: Optical coherence tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coloured photography	Other	Coloured photography will be performed preoperatively and at 3 and 6 months postoperatively.	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best Corrected Visual Acuity	Best Corrected Visual Acuity (BCVA) will be recorded.	6 months post-procedure

Secondary Outcomes

Measure	Description	Time Frame
Intra ocular pressure	Intra ocular pressure (IOP) will be recorded.	6 months post-procedure
Central macular thickness (CMT)	Central macular thickness (CMT) will be recorded.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥18 years.
Both sexes.
Patients with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME).

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hatem F Abd Elfatah, MD	Contact	00201001859927		tito78@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University	Recruiting	Cairo		11591	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Types

Study Protocol

Time Frame

After the end of study for one year.

Access Criteria

The data will be available upon a reasonable request from the corresponding author.

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D041622	Tomography, Optical
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D014054	Tomography
D008919	Investigative Techniques