Comparing Refractive and Visual Outcomes of MIGS and Traditional Surgeries



Status:Enrolling by invitation
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:12/12/2018
Start Date:August 1, 2018
End Date:June 15, 2019

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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.

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.

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)
We found this trial at
1
site
Philadelphia, Pennsylvania 19107
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mi
from
Philadelphia, PA
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