Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Changes of Macular Vasculature After Uncomplicated Phacoemulsification Surgery Using Optical Coherence Tomography Angiography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04594603
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
Dina Tadros, Tanta University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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

Condition or disease Intervention/treatment
Diabetic Retinopathy Other: Phacoemulsification for cataract

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:

  1. Group (1): Cataract will no diabetic retinopathy
  2. 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: Changes of Macular Vasculature After Uncomplicated Phacoemulsification Surgery Using Optical Coherence Tomography Angiography
Actual Study Start Date : April 13, 2021
Actual Primary Completion Date : December 30, 2021
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Group(1): Cataract with no diabetic retinopathy Other: Phacoemulsification for cataract
Phacoemulsification for removal of cataract
Group (2): Cataract associated with diabetic retinopathy Other: Phacoemulsification for cataract
Phacoemulsification for removal of cataract


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04594603


Contacts
Layout table for location contacts
Contact: Dina SM Tadros, MD 00201224093354 dinasabry@rocketmail.com

Locations
Layout table for location information
Egypt
Tanta University Hospital Recruiting
Tanta, El-Garbeia, Egypt, 31515
Contact: Dina Tadros, MD         
Sponsors and Collaborators
Tanta University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Dina Tadros, Lecturer of Ophthalmology, Tanta University, Egypt, Tanta University
ClinicalTrials.gov Identifier: NCT04594603    
Other Study ID Numbers: 34082/9/20
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Time Frame: 3 months
Access Criteria: Link

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases