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

NCT ID: NCT03571139

Last Updated: 2018-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-01-31

Brief Summary

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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

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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

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Diabetic Retinopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Phacoemulsification

Intervention Type DEVICE

Cataract surgery and in the bag posterior chamber lens implantation

Interventions

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Phacoemulsification

Cataract surgery and in the bag posterior chamber lens implantation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Abeer Tawfik Al Hanaineh

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abeer T Al Hanaineh, MSc

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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German Eye Center

Amman, , Jordan

Site Status RECRUITING

Countries

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Jordan

Central Contacts

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Abeer T Al Hanaineh, MSc

Role: CONTACT

0096279184460

Facility Contacts

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Ibrahim Al-Nawaiseh, MD

Role: primary

00962795667760

Other Identifiers

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Abeer T Al Hanaineh

Identifier Type: -

Identifier Source: org_study_id

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