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Viscotrabeculotomy in Pediatric Glaucoma Following Cataract Surgery

Primary Purpose

Glaucoma Congenital

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
single-site rigid probe viscotrabeculotomy (VT)
two-site rigid probe viscotrabeculotomy (VT)
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma Congenital focused on measuring Pediatric glaucoma,, Trabeculotomy, Congenital cataract surgery

Eligibility Criteria

2 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Patients aged ≤ 12 years and required surgery for glaucoma following congenital cataract surgery (GFCS) with or without intraocular lens (IOL) implantation.

Exclusion Criteria:

  • Eyes in which the trabeculotomy involves <180° of Schlemm's canal.
  • Eyes that have synechial angle closure over ≥ 90°.
  • Eyes that have previous procedures other than lensectomy or IOL implantation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    single-site VT group

    two-site VT group

    Arm Description

    Viscotrabeculotomy is performed through a superonasal triangular scleral flap.

    Viscotrabeculotomy is performed through a superonasal and an inferotemporal triangular scleral flap.

    Outcomes

    Primary Outcome Measures

    the success rate in lowering IOP
    Success is defined as IOP between 6-20 mmHg or 35% IOP reduction with or without topical anti-glaucoma medications and without visually-devastating complications or additional glaucoma surgery. IOP was evaluted during each Follow up visit using applanation tonometry.

    Secondary Outcome Measures

    Intraocular pressure (IOP) control values
    measured at each follow up visit using tonopen ,icare or applantion tonometery
    antiglaucoma medications.
    The total number of antiglaucoma medications needed to control the IOP
    postoperative complications
    Include: Hyphaema with its grades, IOP spikes and Hypotony and possible inflammation or infections
    horizontal corneal diameter.
    Measured manually during follow visits using a caliber
    axial length.
    Measured by A scan mode of the US
    cup- disc ratio.
    Detected clinically and documented by fundus photo

    Full Information

    First Posted
    August 6, 2021
    Last Updated
    August 13, 2021
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05011747
    Brief Title
    Viscotrabeculotomy in Pediatric Glaucoma Following Cataract Surgery
    Official Title
    Long Term Surgical Outcomes of Viscotrabeculotomy in Pediatric Glaucoma Following Cataract Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Long term Surgical Outcomes of Viscotrabeculotomy in Pediatric Glaucoma Following Cataract Surgery. Purpose: This study aims to compare outcomes of single-site rigid probe viscotrabeculotomy (VT) to two-site VT in pediatric secondary glaucoma following cataract surgery. Methods: This is a comparative study was performed on patients aged ≤ 12 years and required surgery for glaucoma following congenital cataract surgery (GFCS) with or without intraocular lens (IOL) implantation. Eyes in which the trabeculotomy involves <180° of Schlemm's canal ,eyes that have synechial angle closure over ≥ 90° and eyes that have previous procedures other than lensectomy or IOL implantation are excluded from the study. Eyes are then randomized to undergo single-site VT or two-site VT using a random table. The two-site VT by the rigid probe trabeculotome is performed through a superonasal and an inferotemporal triangular scleral flap. Intraocular pressure (IOP), anti-glaucoma medications, complications and success rates at dates of follow up are all reported. Success is defined as IOP between 6-20 mmHg or 35% IOP reduction with or without topical anti-glaucoma medications and without visually-devastating complications or additional glaucoma surgery.
    Detailed Description
    Long term Surgical Outcomes of Viscotrabeculotomy in Pediatric Glaucoma Following Cataract Surgery. Introduction: Despite advances in congenital cataract management, secondary glaucoma (SG) remains a major postoperative sight-threatening complication, with open-angle glaucoma being the predominant type in both aphakic and pseudophakic children . Although the pathogenesis of glaucoma after cataract surgery remains unclear, several risk factors have been identified. These include early surgery, chronic postoperative inflammation , primary posterior capsulotomy , persistence of fetal vasculature , and microphthalmia . However, the pathogenesis of the classic, open-angle type of glaucoma that develops on average 1.3-12.2 years following uneventful cataract surgery is still obscure. Mechanical collapse of the trabecular meshwork due to the loss of ciliary body tension could be one of the possible reasons. Some speculate that obstruction of the trabecular meshwork by inflammatory cells, lens remnants and vitreous-derived factors may result in delayed elevation in IOP. Arrest of postnatal angle maturation secondary to the surgical intervention could be a contributing factor, especially that aphakic glaucoma is more likely to occur in patients who had lensectomy at a younger age, usually the first year of life. The incidence of secondary pediatric glaucoma after cataract surgery is not yet precisely identified. It ranges from 3%-41% depending on the follow-up period and the criteria chosen to define glaucoma . Management of paediatric glaucoma following cataract surgery (GFCS) is challenging. Trabeculectomy has a poor success rate and precludes the use of contact lenses, especially in the presence of thin, avascular, cystic blebs . Glaucoma drainage devices have a higher chance of success than trabeculectomy, but aphakic eyes have relatively higher rates of complications, especially suprachoroidal haemorrhage, if hypotony occurs particularly if buphthalmic. GDD-implanted eyes also carry a life-long risk of developing keratopathy secondary to endothelial decompensation from the tube end .Cyclodestructive procedures provide a temporizing treatment with occasional longterm control after multiple treatments. Yet, it is difficult to titrate with marked inflammation and a risk of phthisis, especially in microphthalmic eyes. Furthermore, it may be associated with chronic hypotony and may prejudice future surgery to failure. Angle surgery was first described as a surgical option in GFCS by Chen et al., yielding promising results in terms of IOP lowering and surgical success. Unlike bleb-based procedures, angle surgery addresses the more physiological outflow pathway through the trabecular meshwork and Schlemm's canal. Hence the risk of bleb-based complications such as infection, bleb leak, overfiltration and bleb dysthesia is reduced. With the growing evidence that circumferential trabeculotomy yields superior results to conventional 180° angle surgery in primary congenital glaucoma16, Freedman et al. retrospectively reported the results of microcatheter-assisted circumferential trabeculotomy in GFCS, achieving a 72% success rate. several reports in treatment of pediatric glaucoma have concluded that the use of viscoelastic materials during trabeculotomy may increase the success rate of the procedure by preventing ocular decompression, postoperative hemorrhage, anterior chamber shallowness, and adhesion of the incision lips or fibroblastic proliferation18.The purpose of the present study was to compare outcomes of single-site rigid probe viscotrabeculotomy (VT) Versus two-site VT in pediatric secondary glaucoma following cataract surgery. Patients and methods: This is a comparative study , performed on patients aged ≤ 12 years and required surgery for glaucoma following congenital cataract surgery (GFCS) with or without intraocular lens (IOL) implantation. The study will be conducted at the outpatient clinic of Mansoura Ophthalmic Center of Mansoura University in Mansoura, Egypt. Eyes in which the trabeculotomy involves <180° of Schlemm's canal ,eyes that have synechial angle closure over ≥ 90° and eyes that have previous procedures other than lensectomy or IOL implantation are excluded from the study. Eyes are then randomized to undergo single-site VT or two-site VT using a random table. The two-site VT by the rigid probe trabeculotome is performed through a superonasal and an inferotemporal triangular scleral flap. The primary outcome of this study is compare the success rate in lowering IOP between the 2 surgical options; the single-site VT versus two-site VT. Success is defined as IOP between 6-20 mmHg or 35% IOP reduction with or without topical anti-glaucoma medications and without visually-devastating complications or additional glaucoma surgery. The secondary clinical outcomes will include Intraocular pressure (IOP) control values, horizontal corneal diameter, axial length, cup- disc ratio, antiglaucoma medication, refractive error and postoperative complications in these 2 surgical procedures. Data will be analysed. Statistical analysis: All statistical analysis was accomplished using IBM SPSS version 20. Assessment of the data normality was done using both Histogram plot and Shapiro-Wilk's test. Wilcoxon test was used to compare the preoperative and postoperative variables in each group. The comparison between the two groups was done using Mann-Whitney test for numerical variables and Chi-square test for categorical variables. Kaplan-Meier survival curve was plotted to estimate the mean survival time and probabilities of failure at different follow-up stages in the both groups. For all tests, P value of less than 0.05 was considered significant.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma Congenital
    Keywords
    Pediatric glaucoma,, Trabeculotomy, Congenital cataract surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    single-site VT group
    Arm Type
    Active Comparator
    Arm Description
    Viscotrabeculotomy is performed through a superonasal triangular scleral flap.
    Arm Title
    two-site VT group
    Arm Type
    Active Comparator
    Arm Description
    Viscotrabeculotomy is performed through a superonasal and an inferotemporal triangular scleral flap.
    Intervention Type
    Procedure
    Intervention Name(s)
    single-site rigid probe viscotrabeculotomy (VT)
    Intervention Description
    single-site VT by the rigid probe trabeculotome is performed through a superonasal triangular scleral flap.
    Intervention Type
    Procedure
    Intervention Name(s)
    two-site rigid probe viscotrabeculotomy (VT)
    Intervention Description
    Two-site VT by the rigid probe trabeculotome is performed through a superonasal and an inferotemporal triangular scleral flap.
    Primary Outcome Measure Information:
    Title
    the success rate in lowering IOP
    Description
    Success is defined as IOP between 6-20 mmHg or 35% IOP reduction with or without topical anti-glaucoma medications and without visually-devastating complications or additional glaucoma surgery. IOP was evaluted during each Follow up visit using applanation tonometry.
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Intraocular pressure (IOP) control values
    Description
    measured at each follow up visit using tonopen ,icare or applantion tonometery
    Time Frame
    3 years
    Title
    antiglaucoma medications.
    Description
    The total number of antiglaucoma medications needed to control the IOP
    Time Frame
    3 years
    Title
    postoperative complications
    Description
    Include: Hyphaema with its grades, IOP spikes and Hypotony and possible inflammation or infections
    Time Frame
    3 years
    Title
    horizontal corneal diameter.
    Description
    Measured manually during follow visits using a caliber
    Time Frame
    3 years
    Title
    axial length.
    Description
    Measured by A scan mode of the US
    Time Frame
    3 yeras
    Title
    cup- disc ratio.
    Description
    Detected clinically and documented by fundus photo
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Months
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: -Patients aged ≤ 12 years and required surgery for glaucoma following congenital cataract surgery (GFCS) with or without intraocular lens (IOL) implantation. Exclusion Criteria: Eyes in which the trabeculotomy involves <180° of Schlemm's canal. Eyes that have synechial angle closure over ≥ 90°. Eyes that have previous procedures other than lensectomy or IOL implantation.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amr Mohammed Elsayed A Mohammed, MD, FRCS
    Phone
    01004314242
    Ext
    +20
    Email
    dramrabdelkader@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed S Elwehidy, MD
    Phone
    01009922107
    Ext
    +2
    Email
    aselwehidy@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    IPD will be provided as a supplementary digital content
    IPD Sharing Time Frame
    3 years
    IPD Sharing Access Criteria
    IPD will be provided as a supplementary digital content with publication

    Learn more about this trial

    Viscotrabeculotomy in Pediatric Glaucoma Following Cataract Surgery

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