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Surgical and Refractive Outcomes of Combined Glaucoma Surgery

Primary Purpose

Glaucoma, Ocular Hypertension, Filtering Surgery

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
phacotrabeculectomy
ExPress antiglaucoma surgery combined with phacoemulsification
Sponsored by
Medical University of Bialystok
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma combined surgery, postoperative astigmatism, postsurgery refractive error

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Glaucoma with coexisting cataract graded Nuclear-Cortical 1 (NC1) and Nuclear-Cortical 2 (NC2), according to the The Lens Opacities Classification System III (LOCS III scale), was an indication for surgery.
  • Patients with primary open-angle glaucoma (POAG), pseudoexfoliation glaucoma (PXG) and pigmentary glaucoma (PG), in which satisfactory intraocular pressure (IOP >21 mmHg) was not achieved despite maximally-tolerated topical and systemic medication, were qualified for treatment.
  • Additional inclusion criteria were as follows: well documented progression of visual field defects, significant diurnal variations in the IOP, poor patient compliance, and allergy to topical drugs.

Exclusion Criteria:

  • Lack of consent to participate in the study,
  • History of eye surgery or laser procedures within the eye,
  • Closed or narrow angle glaucoma,
  • Diabetes,
  • Advanced macular degeneration
  • Active inflammatory disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    phacotrabeculectomy

    ExPress device implantation

    Arm Description

    patients undergoing phacotrabeculectomy

    patients undergoing ExPress antiglaucoma surgery combined with phacoemulsification

    Outcomes

    Primary Outcome Measures

    IOP
    the change in the level of intraocular pressure

    Secondary Outcome Measures

    Best corrected visual acuity (BCVA)
    the change in the best corrected visual acuity
    astigmatism
    the change in the value of astigmatism with the use of autokeratorefractometer before and after surgery

    Full Information

    First Posted
    March 28, 2020
    Last Updated
    April 3, 2020
    Sponsor
    Medical University of Bialystok
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04335825
    Brief Title
    Surgical and Refractive Outcomes of Combined Glaucoma Surgery
    Official Title
    Surgical and Refractive Outcomes of Combined Phaco-ExPress Versus Phacotrabeculectomy - 6 Months Results.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    January 1, 2019 (Actual)
    Study Completion Date
    December 30, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University of Bialystok

    4. Oversight

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

    5. Study Description

    Brief Summary
    The aim of the study is to examine surgical and refractive outcomes of glaucoma combined surgery in six months period of follow up
    Detailed Description
    Trabeculectomy and implantation of the Ex-Press device belong to the same group of anti-glaucoma procedures improving subconjunctival outflow. The most frequently performed glaucoma surgery of choice is still trabeculectomy, although the less invasive implantation of the Ex-Press device is also an effective alternative. Despite the wide application of these two techniques, their impact on postoperative refraction is not entirely known. Quite often, in the early postoperative period there is a decrease in visual function, which is short-term, although there are reports that it can last up to a year after surgery. It can be caused by a reduction in IOP, as well as the direct effect of trabeculectomy on corneal topography, and thus on postoperative astigmatism and refractive error. The occurrence of astigmatism after trabeculectomy has been widely documented Combined operations of implanting the ExPress implant with cataract phacoemulsification differ from phacotrabeculectomy in that, they do not require cutting of the sclera, cutting the limbus and using a punch. The purpose of our research was to compare the phacotrabeculectomy and phacoemulsification combined with Express device implantation in terms of incidence of postoperative astigmatism in a prospective randomized study, and to attempt to determine what factors determine its size.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Ocular Hypertension, Filtering Surgery
    Keywords
    glaucoma combined surgery, postoperative astigmatism, postsurgery refractive error

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    phacotrabeculectomy
    Arm Type
    Active Comparator
    Arm Description
    patients undergoing phacotrabeculectomy
    Arm Title
    ExPress device implantation
    Arm Type
    Active Comparator
    Arm Description
    patients undergoing ExPress antiglaucoma surgery combined with phacoemulsification
    Intervention Type
    Procedure
    Intervention Name(s)
    phacotrabeculectomy
    Intervention Description
    combined antiglaucoma procedure: trabeculectomy with phacoemulsification
    Intervention Type
    Procedure
    Intervention Name(s)
    ExPress antiglaucoma surgery combined with phacoemulsification
    Intervention Description
    combined antiglaucoma procedure: ExPress device implantation with phacoemulsification
    Primary Outcome Measure Information:
    Title
    IOP
    Description
    the change in the level of intraocular pressure
    Time Frame
    baseline and six months after surgery
    Secondary Outcome Measure Information:
    Title
    Best corrected visual acuity (BCVA)
    Description
    the change in the best corrected visual acuity
    Time Frame
    baseline and six months after surgery
    Title
    astigmatism
    Description
    the change in the value of astigmatism with the use of autokeratorefractometer before and after surgery
    Time Frame
    baseline and six months after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Glaucoma with coexisting cataract graded Nuclear-Cortical 1 (NC1) and Nuclear-Cortical 2 (NC2), according to the The Lens Opacities Classification System III (LOCS III scale), was an indication for surgery. Patients with primary open-angle glaucoma (POAG), pseudoexfoliation glaucoma (PXG) and pigmentary glaucoma (PG), in which satisfactory intraocular pressure (IOP >21 mmHg) was not achieved despite maximally-tolerated topical and systemic medication, were qualified for treatment. Additional inclusion criteria were as follows: well documented progression of visual field defects, significant diurnal variations in the IOP, poor patient compliance, and allergy to topical drugs. Exclusion Criteria: Lack of consent to participate in the study, History of eye surgery or laser procedures within the eye, Closed or narrow angle glaucoma, Diabetes, Advanced macular degeneration Active inflammatory disease.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified data of each participant will be available upon email request for all primary and secondary outcome measures
    IPD Sharing Time Frame
    Data will be available on email request for six months after completing the study
    IPD Sharing Access Criteria
    e mail request, after Data Access Agreement is sign
    Citations:
    PubMed Identifier
    29177182
    Citation
    Chan HHL, Kong YXG. Glaucoma surgery and induced astigmatism: a systematic review. Eye Vis (Lond). 2017 Nov 17;4:27. doi: 10.1186/s40662-017-0090-x. eCollection 2017.
    Results Reference
    result
    PubMed Identifier
    9640570
    Citation
    Hong YJ, Choe CM, Lee YG, Chung HS, Kim HK. The effect of mitomycin-C on postoperative corneal astigmatism in trabeculectomy and a triple procedure. Ophthalmic Surg Lasers. 1998 Jun;29(6):484-9.
    Results Reference
    result
    PubMed Identifier
    27621788
    Citation
    Alvani A, Pakravan M, Esfandiari H, Safi S, Yaseri M, Pakravan P. Ocular Biometric Changes after Trabeculectomy. J Ophthalmic Vis Res. 2016 Jul-Sep;11(3):296-303. doi: 10.4103/2008-322X.188399.
    Results Reference
    result

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    Surgical and Refractive Outcomes of Combined Glaucoma Surgery

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