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Anterior Segment Changes by Optical Coherence Tomography (OCT) in Phaco- Trabeculectomy

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: NCT03626675
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
shymaa kamel Ibrahim Hady, Assiut University

Brief Summary:
  1. Develop a measurement protocol by OCT imaging and characterization of the anterior chamber change in glaucoma patients before and after surgery.
  2. Show the effect of combined surgery in control of intra ocular pressure.

Condition or disease Intervention/treatment Phase
Angle Closure Glaucoma Glaucoma Cataract Secondary Procedure: phaco- trabeculectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Anterior Segment Changes Before and After Uneventful Combined Phaco-Trabeculectomy by Using Optical Coherence Tomography (OCT)
Estimated Study Start Date : October 15, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
study group

They will be subjected to:

Preoperative A-complete ophthalmic examination will be done for every patient; B- Biometric parameters measured with the AS‑OCT C- Medical fitness for all patients D- Informed consent will be obtained from all patients after through explanation of operation and its potential benefits and risks.

Surgery combined Phaco trabeculectomy

Post operative:

-Follow-up examinations will be performed for every patient at 1day, 1 week, 1 and 3 months postoperatively.

and biometric parameters measured with the AS‑OCT before and after the surgery will be used to collect the data.

-The data will be managed and analysed with confidentiality by scientifically qualified persons

Procedure: phaco- trabeculectomy
combined phaco-trabeculectomy surgery




Primary Outcome Measures :
  1. Biometric parameters measured with the AS‑OCT (AC depth (ACD)) after surgery. - anterior chamber depth in mm [ Time Frame: one week post operative ]
    anterior chamber depth in mm Distance from corneal endothelium to anterior surface of the lens


Secondary Outcome Measures :
  1. other biometric parameters measured with the AS‑OCT, [ Time Frame: 1,3,6, month postoperative ]

    Parameter Unit

    Iris thickness μT Iris curvature μC AC width μC Angle opening distance μO Angle recess area μR Trabecular iris angle Degrees Lens vault μV


  2. intra ocular pressure [ Time Frame: 1,3,6, month postoperative ]
    intra ocular pressure in mm hg



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged over 18 years
  • Diagnosed primary open angle glaucoma
  • Visual field defects and optic nerve head appearance characteristic for glaucoma
  • Angle closure predisposition as evidenced from gonioscopy.
  • Neovascularization in the anterior chamber angle
  • pseudo-exfoliation glaucoma as evidenced from slit lamp examination
  • No cataract surgery.
  • No glaucoma surgery
  • No degenerative changes in the retina in funduscopy after mydriasis

Exclusion Criteria:

  • -previous glaucoma surgery
  • Previous cataract surgery
  • Presence of any abnormalities preventing reliable measurements
  • Ocular inflammation and ocular disease interfering with the study
  • Corneal, macula, and other corneal disease.
  • No fixation Funds lesions such as diabetic retinopathy or retinal detachment.

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): NCT03626675


Contacts
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Contact: Ehab I Wasfy, professor 01000373344 wasfiehab@hotmail.com
Contact: Mahmoud F Rateb, Lecturer 01008348480 Rateb.eye@gamil.com

Locations
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Egypt
Assiut university Recruiting
Assiut, Egypt
Contact: shymaa K H    01069541100    shymaakamel@aun.edu.eg   
Contact: Omar M Ali, proffeser         
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Omar M Ali, MD,professor Assiut University
Publications of Results:
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Responsible Party: shymaa kamel Ibrahim Hady, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03626675    
Other Study ID Numbers: ASCBAPTBUOCT
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Cataract
Glaucoma, Angle-Closure
Ocular Hypertension
Eye Diseases
Lens Diseases