Comparing Refractive and Visual Outcomes of MIGS and Traditional Surgeries

Comparing Refractive and Visual Outcomes of Minimally Invasive and Traditional Glaucoma Surgeries

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Ocular Hypertension; Glaucoma

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from the Wills Eye Hospital Glaucoma Service who are in need of glaucoma and/or cataract surgery.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biometry prediction accuracy	Difference between the target refraction and the spherical equivalent of the final refraction following surgery.	Baseline, Post-op Month 1, Post-op Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative corneal curvature	Variation in corneal curvature (astigmatism) following surgery.	Baseline, Post-op Month 1, Post-op Month 3

Collaborators and Investigators

• Sponsor: Wills Eye
• Collaborators: Allergan; The American Society of Cataract and Refractive Surgery Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: June 29, 2018
• First Posted (ACTUAL): July 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: glaucoma surgery; visual outcomes; MIGS, minimally invasive glaucoma surgery; refractive outcomes
• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Ocular Hypertension
• Other Study ID Numbers: 18-689E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No