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Triple Procedure for Dense Cataractus Neovascular Glaucoma Patients (NVG)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04143620
Recruitment Status : Completed
First Posted : October 29, 2019
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Shaaban Elwan, Minia University

Brief Summary:

Background: One of the most difficult refractory glaucomas in treatment is the neovascular type and its association with dense cataract add to this difficulty. This study aimed to provide results of triple surgical treatment of such conditions.

Methods: A total of 12 eyes of 12 patients with dense cataractus NVG patients were included in this study. The patients mean age was 57.25 ± 5.9 years. The mean pre-operative intraocular pressure (IOP) was 47.25 ± 4.04 mmHg with maximum antiglaucoma therapy. The mean best corrected distant visual acuities (BCDVA) in log MAR was 2.13 ± 0.38. All the patients received intra-vitreal injection of 1.25 mg (0.05 ml) bevacizumab followed by phacoemulsification, pars plana vitrectomy (PPV) including pan-retinal photocoagulation (PRP), and assisted trabeculectomy with Mitomycin c (MMC). Mean IOP and BCDVA changes were the main outcome results of this study.


Condition or disease Intervention/treatment Phase
IOP Decreased Visual Impairment Procedure: Procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Manegment of uncontrolled NVG patients with dense cataract
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Triple Procedure for Dense Cataractus Neovascular Glaucoma Patients
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Neovascular glaucoma
Neovascular glaucoma patients underwent triple procedure
Procedure: Procedure
Triple procedure
Other Name: Triple procedure




Primary Outcome Measures :
  1. BCDVA [ Time Frame: 2 years ]
    Best corrected distant visual acuity

  2. IOP [ Time Frame: 2 years ]
    Intra-ocular pressure


Secondary Outcome Measures :
  1. Post-operative complications [ Time Frame: 2 years ]
    Post-operative complications



Information from the National Library of Medicine

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Ages Eligible for Study:   47 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The study included patients with uncontrolled angle closure dense cataractus NVG with maximum tolerated anti-glaucoma medications.

Exclusion Criteria:

  • Excluded from this study eyes that had previous anti-glaucoma procedures, silicone oil filled eyes, previous buckle surgery or Conjunctival scaring from any cause, eyes with clear crystalline lens or faint cataract, eyes with corneal opacity, and eyes with visual acuity less than hand motion with good perception of light.

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): NCT04143620


Locations
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Egypt
Minia University
Minya, Egypt, 61519
Sponsors and Collaborators
Minia University
Investigators
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Study Chair: Hossam M Moharram, MD Minia University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shaaban Elwan, Assistant professor of ophthalmology, Minia University
ClinicalTrials.gov Identifier: NCT04143620    
Other Study ID Numbers: Minia University, NVG
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results of the study
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 2 years
Access Criteria: study results

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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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Vision Disorders
Vision, Low
Glaucoma
Glaucoma, Neovascular
Ocular Hypertension
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms