Comparing Refractive and Visual Outcomes of MIGS and Traditional Surgeries

NCT03584958 | Unknown

• 1 other identifier: 18-689E
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Ocular Hypertension

Keywords

glaucoma surgery; MIGS, minimally invasive glaucoma surgery; refractive outcomes; visual outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post-operative corneal curvature

  Baseline, Post-op Month 1, Post-op Month 3

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Daniel Lee, MD

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 12, 2018
• Study Start: August 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)