Comparing Refractive and Visual Outcomes of MIGS and Traditional Surgeries

NCT ID: NCT03584958

Last Updated: 2022-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Glaucoma Ocular Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ab interno goniotomy surgery

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

No interventions assigned to this group

Gelatin stent surgery

Subconjunctival stent (Xen) surgery to decrease intraocular pressure.

No interventions assigned to this group

Suprachoroid stent and cataract surgery

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

No interventions assigned to this group

Trabeculectomy surgery

Glaucoma filtering surgery to decrease intraocular pressure.

No interventions assigned to this group

Cataract surgery

Cataract surgery with no glaucoma procedure.

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role collaborator

The American Society of Cataract and Refractive Surgery Foundation

OTHER

Sponsor Role collaborator

Wills Eye

OTHER

Sponsor Role lead

Responsible Party

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Daniel Lee, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye Hospital

Locations

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Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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18-689E

Identifier Type: -

Identifier Source: org_study_id

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