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Comparing Refractive and Visual Outcomes of MIGS and Traditional Surgeries

Sponsor
Wills Eye (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03584958
Collaborator
Allergan (Industry), The American Society of Cataract and Refractive Surgery Foundation (Other)
150
Enrollment
1
Location
58.9
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary goal of this study is to evaluate refractive and visual outcomes in glaucoma patients who will be having either traditional glaucoma surgery or minimally invasive glaucoma surgery, also known as MIGS.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    There is an increasing number of surgical options to lower intraocular pressure (IOP) in patients with glaucoma and ocular hypertension performed with or without concurrent cataract surgery. Today, patients undergoing glaucoma surgery have increasingly higher expectations for their postoperative visual outcomes. Therefore, it is important to understand the influence of various glaucoma surgical procedures on refractive outcomes. This information would aid in patient and surgical procedure selection, pre-operative counseling to set appropriate expectations and may help surgeons adjust their plans and techniques to improve visual outcomes.

    The advent of minimally invasive glaucoma surgery (MIGS) procedures further highlights the importance of studying refractive outcomes as many of these surgeries are being performed earlier in the glaucoma severity spectrum where central visual potential is still preserved. Furthermore, this class of surgeries is often performed in combination with cataract surgery.

    There remains a lack of data regarding refractive outcomes in patients who have had phaco-iStent, phaco-Cypass, as well as goniotomy (Kahook dual blade (KDB) gonioscopy assisted transluminal trabeculotomy), and Xen gel stent implantation with or without cataract surgery. This information would help during pre-operative patient discussions and lens selection in the context of a combined procedure.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparing Refractive and Visual Outcomes of Minimally Invasive and Traditional Glaucoma Surgeries
    Actual Study Start Date :
    Aug 1, 2018
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Jun 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Ab interno goniotomy surgery

    Gonioscopy-assisted transluminal trabeculotomy (GATT) surgery to decrease intraocular pressure.
    Gelatin stent surgery

    Subconjunctival stent (Xen) surgery to decrease intraocular pressure.
    Suprachoroid stent and cataract surgery

    Suprachoroidal stent (Cypass) to decrease intraocular pressure in combination with cataract surgery.
    Trabeculectomy surgery

    Glaucoma filtering surgery to decrease intraocular pressure.
    Cataract surgery

    Cataract surgery with no glaucoma procedure.

    Outcome Measures

    Primary Outcome Measures

    1. Biometry prediction accuracy [Baseline, Post-op Month 1, Post-op Month 3]

      Difference between the target refraction and the spherical equivalent of the final refraction following surgery.

    Secondary Outcome Measures

    1. Post-operative corneal curvature [Baseline, Post-op Month 1, Post-op Month 3]

      Variation in corneal curvature (astigmatism) following surgery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Diagnosis of glaucoma or ocular hypertension in the study eye(s) and are consented to receive any of the following procedures:

    • Ab interno goniotomy surgery: Gonioscopy-assisted transluminal trabeculotomy (GATT) surgery to decrease intraocular pressure.

    • Gelatin stent surgery: Subconjunctival stent (Xen) surgery to decrease intraocular pressure.

    • Suprachoroidal stent and cataract surgery: Suprachoroidal stent (Cypass) to decrease intraocular pressure in combination with cataract surgery.

    • Trabeculectomy surgery: Glaucoma filtering surgery to decrease intraocular pressure.

    • Cataract surgery: Cataract surgery with no glaucoma procedure.

    Exclusion Criteria:

    Patients with previous corneal ectasia or history of refractive procedures; patients who cannot fixate well due to poor vision (worse than 20/200)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wills Eye Hospital Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Wills Eye
    • Allergan
    • The American Society of Cataract and Refractive Surgery Foundation

    Investigators

    • Principal Investigator: Daniel Lee, MD, Wills Eye Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daniel Lee, MD, Principal Investigator, Wills Eye
    ClinicalTrials.gov Identifier:
    NCT03584958
    Other Study ID Numbers:
    • 18-689E
    First Posted:
    Jul 12, 2018
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Daniel Lee, MD, Principal Investigator, Wills Eye
    glaucoma surgery
    MIGS, minimally invasive glaucoma surgery
    refractive outcomes
    visual outcomes
    Additional relevant MeSH terms:
    Glaucoma
    Ocular Hypertension

    Study Results

    No Results Posted as of Mar 29, 2022