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Comparing Refractive and Visual Outcomes of MIGS and Traditional Surgeries

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ClinicalTrials.gov Identifier: NCT03584958
Recruitment Status : Enrolling by invitation
First Posted : July 12, 2018
Last Update Posted : December 10, 2018
Sponsor:
Collaborators:
Allergan
The American Society of Cataract and Refractive Surgery Foundation
Information provided by (Responsible Party):
Daniel Lee, MD, Wills Eye

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
Glaucoma Ocular Hypertension

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.


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Study Type : Observational
Estimated 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 : August 1, 2018
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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.



Primary Outcome Measures :
  1. Biometry prediction accuracy [ Time Frame: 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 [ Time Frame: Baseline, Post-op Month 1, Post-op Month 3 ]
    Variation in corneal curvature (astigmatism) following surgery.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584958


Locations
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United States, Pennsylvania
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Allergan
The American Society of Cataract and Refractive Surgery Foundation
Investigators
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Principal Investigator: Daniel Lee, MD Wills Eye Hospital

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Responsible Party: Daniel Lee, MD, Principal Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT03584958     History of Changes
Other Study ID Numbers: 18-689E
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Daniel Lee, MD, Wills Eye:
glaucoma surgery
MIGS, minimally invasive glaucoma surgery
refractive outcomes
visual outcomes

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases