GlaucomaNCT03584958
Comparing Refractive and Visual Outcomes of MIGS and Traditional Surgeries
An observational study of Glaucoma and Ocular Hypertension, run by Wills Eye at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the Wills Eye Hospital Glaucoma Service who are in need of glaucoma and/or cataract surgery.
Who may be able to join
- 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.
Who cannot join
- Patients with previous corneal ectasia or history of refractive procedures; patients who cannot fixate well due to poor vision (worse than 20/200)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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.
Read the 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.
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- glaucoma surgery, MIGS, minimally invasive glaucoma surgery, refractive outcomes, visual outcomes
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Biometry prediction accuracy
Difference between the target refraction and the spherical equivalent of the final refraction following surgery.
Measured: Baseline, Post-op Month 1, Post-op Month 3
Secondary outcomes (1)
Post-operative corneal curvature
Variation in corneal curvature (astigmatism) following surgery.
Measured: Baseline, Post-op Month 1, Post-op Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start1 Aug 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan, The American Society of Cataract and Refractive Surgery Foundation
- Responsible party
- Principal investigator, Daniel Lee, MD, Wills Eye
- Investigators
- Daniel Lee, MD, Principal investigator, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584958
- Sponsor's protocol ID
- 18-689E
- Status last verified
- Mar 2022
- First submitted
- 29 Jun 2018
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Refractive and Visual Outcomes of Minimally Invasive and Traditional Glaucoma Surgeries
- ClinicalTrials.gov ID
- NCT03584958
- Acronym / sponsor ID
- 18-689E
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- glaucoma surgery, MIGS, minimally invasive glaucoma surgery, refractive outcomes, visual outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Allergan, The American Society of Cataract and Refractive Surgery Foundation
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the Wills Eye Hospital Glaucoma Service who are in need of glaucoma and/or cataract surgery.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with previous corneal ectasia or history of refractive procedures; patients who cannot fixate well due to poor vision (worse than 20/200)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Post-operative corneal curvature
Time frame: Baseline, Post-op Month 1, Post-op Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Lee, MD principal investigator
Wills Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Ocular Hypertension, run by Wills Eye at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biometry prediction accuracy (time frame: Baseline, Post-op Month 1, Post-op Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.