Abstract
Introduction Trabeculectomy is the 'gold standard' of the initial open-angle glaucoma surgical procedure worldwide. Over the past decade, the introduction of minimally invasive procedures, including new blistering procedures such as MicroShunt, has changed the approach to treating glaucoma. There is currently insufficient evidence to compare the effectiveness of these procedures and trabeculectomy. In addition, data on patient impact and cost-effectiveness are not available. This study was designed to fill this evidence gap and determine whether MicroShunt implantation is not inferior to trabeculectomy in terms of efficacy and cost-effectiveness. Methodology Angle glaucoma will be performed with indications for surgery. Patients who had previously undergone ophthalmic surgery other than phacoemulsification were excluded, as were patients with underlying ocular conditions affecting the field of vision or requiring complex surgery. Following informed consent, patients will be randomized to either a PRESERFLO™ MicroShunt intervention group or a trabeculectomy control group using block randomization (blocks of 2, 4, or 6 patients). A total of 124 patients will be randomized 1:1 by site. The primary endpoint will be intraocular pressure (IOP) one year after surgery. Secondary outcomes included use of IOP-lowering medications, treatment failure, visual acuity, visual field progression, additional interventions, adverse events, patient-reported outcome measures (PROMs), and cost-effectiveness. Test results will be measured for 12 months after surgery. Discussion This study protocol describes the design of a multicenter, randomized, controlled non-inferiority study. No cost-benefit study evaluating MicroShunt has been conducted to date. This multi-center RCT will provide insight into whether MicroShunt implantation is non-inferior to standard trabeculectomy in terms of post-operative intraocular pressure and whether MicroShunt implantation is cost-effective.
| Original language | English |
|---|---|
| Article ID | 43 |
| Page number | 9 |
| Magazine | BMC Ophthalmology |
| tom | 23 |
| issue number | 1 |
| two | |
| publication status | post-January 31, 2023 |
Keywords
- micro shunt
- Trabeculectomy
- Innovative surgery for follicular glaucoma
- glaucoma
- intraocular pressure
- Patient-reported outcome measures
- randomized controlled trial
- Profitability
- budget impact
- pipe
- result
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Scheres, L.M.J., van den Biggelaar, F.J.H.M., Winkens, B., Kujovic-Aleksov, S., Muskens, R.P.H.M., de Waard, P.W.T., de Crom, R.M.P.C., Ernest, PJG, Pijl, BJ, Ramdas, WD, van Rijn, LJ, Tan, ANL., Dirksen, CD(2023)。Efficacy and Cost Effectiveness of MicroShunt Implantation Compared to Standard Trabeculectomy for Open Angle Glaucoma (SIGHT Study): Study Protocol for a Multicenter Randomized Controlled Study.BMC Ophthalmology,23(1), [43].https://doi.org/10.1186/s12886-022-02734-y
Scheres, LMJ; van den Biggelaar, F.J.H.M.; Winkens, B.Wait. / /Efficacy and Cost Effectiveness of MicroShunt Implantation Compared to Standard Trabeculectomy for Open Angle Glaucoma (SIGHT Study): Study Protocol for a Multicenter Randomized Controlled Study.exist:BMC Ophthalmology2023; lot. 23. 1.
@Article{74d6b62dbea04ef2b88190fb935714e8,
title = "Efficacy and Cost Effectiveness of MicroShunt Implantation Compared to Standard Trabeculectomy for Open Angle Glaucoma (SIGHT Study): Protocol for a Multicenter Randomized Controlled Study",
abstract = "Background Trabeculectomy is globally the {"}gold standard{"} initial surgery for open-angle glaucoma. The introduction of minimally invasive procedures, such as minimally invasive surgery, has changed the glaucoma treatment landscape over the past decade. Methods. Currently no there is insufficient evidence to compare the effectiveness of these procedures and trabeculectomy. In addition, there are no data on patient impact and cost-effectiveness. This study was designed to fill the evidence gap and determine whether MicroShunt implantation after trabeculectomy was equivalent in eye surgery other than phacoemulsification, had comorbidities affecting visual field, or required combined surgery Patients were also excluded After informed consent, patients will be randomized to either intervention, PRESERFLO™ MicroShunt implantation, or control, trabeculectomy, using block randomization (2, 4 or 6 blocks of patients). A total of 124 patients will be randomized 1:1 by site. endpoint will be intraocular pressure (IOP) one year after surgery. Secondary outcomes include use of IOP-lowering medications, treatment failure, visual acuity, visual field progression, additional interventions, adverse events, patient-reported outcome measures (PROM), and cost-effectiveness of results studies will be measured up to 12 months post-procedure Discussion Study protocol describes multicenter equivalence Design of a randomized controlled trial for efficacy To date, no cost-effectiveness studies have been conducted evaluating MicroShunt. This multi-center RCT will provide more insight into whether MicroShunt implantation is non-inferior to standard trabeculectomy in terms of postoperative IOP efficacy and whether MicroShunt implantation would be cost-effective.”,
Keywords = "microshunt, trabeculectomy, new glaucoma surgery, glaucoma, intraocular pressure, patient-reported outcome measure, randomized controlled trial, cost-effectiveness, budget impact, TUBE, outcome",
autor = "LMJ Scheres i {van den Biggelaar}, FJHM i B. Winkens i S. Kujovic-Aleksov i RPHM Muskens i {de Waard}, PWT i {de Crom}, RMPC i PJG Ernest i BJ Arrow l i WD Ramdas i {van Rijn}, LJ i ANL Tan oraz CD Dirksen i HJM Beckers",
Year = "2023",
month = january,
day = "31",
doi = "10.1186/s12886-022-02734-y",
Language = "English",
Volume = "23",
journal = "BMC Ophthalmology",
issn = "1471-2415",
publisher = "BioMed Central Ltd",
number = "1",
}
Scheres, LMJ, van den Biggelaar, FJHM, Winkens, B, Kujovic-Aleksov, S, Musken, RPHM, de Waard, PWT, Chrome, RMPC, Ernest, PJG, Arrow, BJ, Ramdas, WD, van Rijn, LJ, Tan, ANL, Dixon, CD2023, 'Efficacy and Cost Effectiveness of MicroShunt Implantation Compared to Standard Trabeculectomy for Open Angle Glaucoma (SIGHT Study): Study Protocol for a Multicenter Randomized Controlled Study',BMC Ophthalmology, flight. 23, no. 1, 43.https://doi.org/10.1186/s12886-022-02734-y
Efficacy and cost-effectiveness of MicroShunt implantation compared to standard trabeculectomy in the treatment of open-angle glaucoma (SIGHT study): a study protocol for a multicenter, randomized, controlled trial./Scheres, LMJ; van den Biggelaar, F.J.H.M.; Winkens, B.Wait.
exist:BMC Ophthalmology, lot. 23. 1, 43, 31.01.2023.
Search results:Contributions to magazines›article›Academic›peer review
TY - 日
T1 - Efficacy and Cost Effectiveness of MicroShunt Implantation Compared to Standard Trabeculectomy for Open Angle Glaucoma (SIGHT Study): Study Protocol for a Multicenter, Randomized, Controlled Study
AU - Scheres, LMJ
AU - van den Biggelaar, F.J.H.M.
AU – Winkens, B.
AU - Kujovic-Aleksov, S.
AU - Muskens, R.P.H.M.
AU - de Waard, P.W.T.
AU - de Crom, R.M.P.C.
AU - Ernest, P.J.G.
AU - arrowhead, B.J.
AU - Ramdas, W.D.
AU - van Rijn, L.J.
AU - Tan, ANL
AU - Dirksen, CD
AU - Bakers, H.J.M.
Year - 31.01.2023
Y1 - 2023/1/31
N2 - Introduction Trabeculectomy is the 'gold standard' of the initial open-angle glaucoma surgical procedure worldwide. Over the past decade, the introduction of minimally invasive procedures, including new blistering procedures such as MicroShunt, has changed the approach to treating glaucoma. There is currently insufficient evidence to compare the effectiveness of these procedures and trabeculectomy. In addition, data on patient impact and cost-effectiveness are not available. This study was designed to fill this evidence gap and determine whether MicroShunt implantation is not inferior to trabeculectomy in terms of efficacy and cost-effectiveness. Methodology Angle glaucoma will be performed with indications for surgery. Patients who had previously undergone ophthalmic surgery other than phacoemulsification were excluded, as were patients with underlying ocular conditions affecting the field of vision or requiring complex surgery. Following informed consent, patients will be randomized to either a PRESERFLO™ MicroShunt intervention group or a trabeculectomy control group using block randomization (blocks of 2, 4, or 6 patients). A total of 124 patients will be randomized 1:1 by site. The primary endpoint will be intraocular pressure (IOP) one year after surgery. Secondary outcomes included use of IOP-lowering medications, treatment failure, visual acuity, visual field progression, additional interventions, adverse events, patient-reported outcome measures (PROMs), and cost-effectiveness. Test results will be measured for 12 months after surgery. Discussion This study protocol describes the design of a multicenter, randomized, controlled non-inferiority study. No cost-benefit study evaluating MicroShunt has been conducted to date. This multi-center RCT will provide insight into whether MicroShunt implantation is non-inferior to standard trabeculectomy in terms of post-operative intraocular pressure and whether MicroShunt implantation is cost-effective.
AB - Introduction Trabeculectomy is the 'gold standard' in the initial open-angle glaucoma surgical procedure worldwide. Over the past decade, the introduction of minimally invasive procedures, including new blistering procedures such as MicroShunt, has changed the approach to treating glaucoma. There is currently insufficient evidence to compare the effectiveness of these procedures and trabeculectomy. In addition, data on patient impact and cost-effectiveness are not available. This study was designed to fill this evidence gap and determine whether MicroShunt implantation is not inferior to trabeculectomy in terms of efficacy and cost-effectiveness. Methodology Angle glaucoma will be performed with indications for surgery. Patients who had previously undergone ophthalmic surgery other than phacoemulsification were excluded, as were patients with underlying ocular conditions affecting the field of vision or requiring complex surgery. Following informed consent, patients will be randomized to either a PRESERFLO™ MicroShunt intervention group or a trabeculectomy control group using block randomization (blocks of 2, 4, or 6 patients). A total of 124 patients will be randomized 1:1 by site. The primary endpoint will be intraocular pressure (IOP) one year after surgery. Secondary outcomes included use of IOP-lowering medications, treatment failure, visual acuity, visual field progression, additional interventions, adverse events, patient-reported outcome measures (PROMs), and cost-effectiveness. Test results will be measured for 12 months after surgery. Discussion This study protocol describes the design of a multicenter, randomized, controlled non-inferiority study. No cost-benefit study evaluating MicroShunt has been conducted to date. This multi-center RCT will provide insight into whether MicroShunt implantation is non-inferior to standard trabeculectomy in terms of post-operative intraocular pressure and whether MicroShunt implantation is cost-effective.
KW - Microshunt
KW - Trabeculectomy
KW - New surgery for bullous glaucoma
KW - Glaucoma
KW - intraocular pressure
KW - Patient-reported outcome measures
KW - Randomized controlled trials
KW - profitable
KW - Impact on the budget
KW - Pipe
KW - result
U2 - 10.1186/s12886-022-02734-y
DO-10.1186/s12886-022-02734-y
M3 - Articles
C2-36721130
Serial number - 1471-2415
VL-23
JO - BMC Ophthalmology
JF - BMC Ophthalmology
is 1
M1 - 43
So -
Scheres LMJ, van den Biggelaar FJHM, Winkens B, Kujovic-Aleksov S, Muskens RPHM, de Waard PWT 等。Efficacy and Cost Effectiveness of MicroShunt Implantation Compared to Standard Trabeculectomy for Open Angle Glaucoma (SIGHT Study): Study Protocol for a Multicenter Randomized Controlled Study.BMC Ophthalmology2023 Jan 31;23(1):43. doi: 10.1186/s12886-022-02734-y
FAQs
What is the effectiveness of trabeculectomy? ›
Similarly, trabeculotomy 360 procedures performed on patients with refractory primary open-angle glaucoma (POAG) reported a 20% IOP reduction in 59% of patients, with the average number of anti-glaucoma medications dropping from 1.7 ± 1.3 to 1.1 ± 1.0 medications [34].
What is the success rate of glaucoma trabeculectomy? ›The average follow-up time was six years, with 73% of eyes displaying surgical success at the final follow-up. However, this percentage included those who needed additional medical therapy in come capacity. The percentage drops only slightly to 69% of eyes that needed no additional medical therapy.
How much does a trabeculectomy cost? ›During a 5-year time horizon, the mean cost of medical treatment only was $6172, the mean cost of a trabeculectomy was $7872, and the mean cost of a tube insertion was $10 075, resulting in a difference of $1700 (95% CI, $1644-$1770) between medical treatment and trabeculectomy, $3904 (95% CI, $3858-$3953) between ...
What is the difference between Trabeculotomy and trabeculectomy? ›The basic indications for the surgery were as follows: Trabeculectomy was indicated for the cases with moderate to severe visual field loss or need of lower postoperative intraocular pressure, and trabeculotomy indicated for those with early stage of POAG.
What is the most successful glaucoma surgery? ›Research shows that trabeculectomy can lower eye pressure in about 7 out of 10 people. It may work best in people who haven't had an eye injury or another eye surgery.
What is the disadvantage of trabeculectomy? ›THE PROS AND CONS OF TRABECULECTOMY
The drawbacks of trabeculectomy are that its efficacy is unpredictable, and there are too many complications. Patients' postoperative IOP can be too low or too high. Their wound-healing response can be modulated, but not always sufficiently.
At that time point, 48% of patients in the tube surgery group and 39% in the trabeculectomy group had surgical failure.
How many years does a trabeculectomy last? ›For that reason, a trabeculectomy that works well for five to 15 years may be sufficient to prevent significant vision loss in these patients for the rest of their lives.
What is the most common complication of trabeculectomy? ›- Chorioretinal Folds Secondary to Hypotony Maculopathy from an Overfiltering Bleb. ...
- Bleb Leak.
- Choroidal Effusions.
- Overfiltering Bleb.
- Ptosis from Overfiltering Bleb.
- Photos Courtesy of Sarwat Salim, MD, FACS, University of Tennessee.
— Stand-alone microstent implantation and trabeculectomy are both effective at treating glaucoma, with the microstent possibly providing an alternative to trabeculectomy, according to a study presented here.
How long does it take for eye to heal after trabeculectomy? ›
Unlike most laser treatment where the eye recovers very quickly, it can take anywhere from two to six weeks for the eye to recover from a trabeculectomy.
What happens when trabeculectomy fails? ›When a trabeculectomy procedure fails and cannot be rescued, subsequent procedures include a second trabeculectomy, placement of an aqueous shunt, or a cyclodestructive procedure.
What is the benefit of trabeculectomy in open-angle glaucoma? ›Trabeculectomy is the method of reducing IOP in medically uncontrolled patients. A pain-free eye was associated with better quality of life in patients. A successful trabeculectomy helps to preserve the residual vision in such patients.
How painful is a trabeculectomy? ›You may have some watering, sandy sensation or blurring of vision after trabeculectomy, but this should clear within a few days. Soreness and irritation may occur from the sutures or because of the surgery itself. These sensations generally reduce within a few days.
What is the gold standard treatment of glaucoma? ›Selective Laser Trabeculoplasty (SLT): The Gold Standard for Treating Open Angle Glaucoma.
What is the newest surgery for glaucoma? ›Selective laser trabeculoplasty (SLT) reduces intraocular pressure by stimulating increased outflow of fluid from the eye. SLT offers an improved safety profile compared to older glaucoma laser therapies and may lower eye pressure by as much as 20-30%.
What is the newest treatment for glaucoma? ›October 04, 2022 - In a recent press release, Santen announced that the FDA approved OMLONTI, the company's newest ophthalmic medication. This ophthalmic solution is composed of 0.002% omidenepag isopropyl. This drug will lower intraocular pressure (IOP) for patients with ocular hypertension or open-angle glaucoma.
What are the long term complications of a trabeculectomy? ›Reported longer-term complications have included visually-significant cataracts10 with increased rates of cataract extraction post-trabeculectomy;11-14 as well as bleb-related complications, such as hypotony, bleb leak, blebitis, and endophthalmitis.
How long does blurred vision last after trabeculectomy? ›Conclusions: Transient vision loss after trabeculectomy is common and may take up to 2 years for recovery.
What are the risk factors for trabeculectomy failure? ›Younger age, coupled with hypotony and elevated IOP in the immediate postoperative period are risk factors for surgical failure. Repeat trabeculectomy can also be planned in failure cases, as is evident from our study.
What does eye look like after trabeculectomy? ›
After surgery, your eye may be red and irritated. It may also water more than usual or swell a little. Even though your eye may be uncomfortable, it's important not to rub it. Rubbing your eye could damage it.
What is the least invasive glaucoma surgery? ›MIGS is a state-of-the-art minimally invasive glaucoma surgery that uses microscopic instruments to facilitate small incision surgery. It provides a safer option to reduce eye pressure than conventional surgery, with the added benefits of a higher success rate and faster recovery time.
What percentage of glaucoma patients need surgery? ›According to our results, there was 5.3% chance that a patient with OAG would receive surgical treatment within five years of their first diagnosis. A retrospective study using the United States' claims database reported that 4.2% of patients with open-angle glaucoma received surgery within 48 months of diagnosis8.
Can you fly after a trabeculectomy? ›Glaucoma Surgery: With most types of glaucoma surgeries, such as trabeculoplasty or a tube shunt, it is considered safe to fly. However, frequent follow-up visits are often recommended in the first few weeks and we may not advise long distance travel to ensure you can access the care you need.
What should I avoid after glaucoma surgery? ›What Am I Able to Do After Glaucoma Surgery? It's important to consult with your eye doctor for specific timelines regarding your recovery. Caution should be taken when eye pressure is low, and patients should avoid heavy lifting, bending over, vigorous activity or straining.
Can a trabeculectomy be reversed? ›Conventional wisdom holds that glaucoma treatment may preserve vision but cannot reverse damage. Now, researchers at the Jules Stein Eye Institute (JSEI) at UCLA report that damage may be reversible, at least for some patients following trabeculectomy.
What is the success rate of laser eye surgery for glaucoma? ›Selective laser trabeculoplasty is successful in about 80% of patients and can lower eye pressure by as much as 20–30%, on average.
What is the best implant for glaucoma? ›Durysta is indicated for people diagnosed with open-angle glaucoma and ocular hypertension.
Can I use artificial tears after trabeculectomy? ›Although most of the time you won't notice the bleb, occasionally you may feel irritation or a sandy or gritty feeling. Artificial tear lubricants, in most cases, relieve the discomfort.
What causes blurred vision after trabeculectomy? ›Chronic Bleb Leak
Another possible explanation for post-trabeculectomy patients with 20/20 vision but a visual complaint is a bleb leak. Symptoms may include: decreased IOP; occasional tearing; occasional blurry vision; shifting vision quality; and/or the patient says that pressing on the eye causes a change in vision.
What is the best eye surgery for glaucoma? ›
Argon laser trabeculoplasty (ALT) is the most common type of laser surgery. It's usually used to treat open angle glaucoma.
Which is worse open-angle glaucoma or narrow angle glaucoma? ›Closed-angle (or angle-closure) glaucoma makes up less than 20 percent of glaucoma cases in the United States. It's usually more severe than open-angle glaucoma. Both conditions involve changes in the eye that prevent proper drainage of fluid.
Is open-angle glaucoma worse than closed-angle glaucoma? ›In most cases, closed-angle glaucoma is more severe than open-angle glaucoma. Both diseases involve changes in the eye that obstruct proper drainage of fluid. As a result, a buildup of pressure occurs inside the eye, which progressively damages the optic nerve.
What should people with open-angle glaucoma avoid? ›Time to cut out fried foods, baked goods and any product with an ingredient list that includes hydrogenated or partially hydrogenated oils. Saturated foods that include red meat, beef, lard, shortening and oils can also worsen glaucoma.
Are you awake for trabeculectomy? ›You may be awake during the surgery. You will receive a medicine to help you relax. You may also receive a shot (injection) or a topical numbing medicine (anesthetic) to numb the eye. This will keep you from feeling anything during the surgery.
What is the survival rate of trabeculectomy? ›Long-term, trabeculectomy has been proven to have a high success rate. It's estimated that 90 percent were successful, with two-thirds of individuals no longer needing medication to control the condition afterward. Approximately 10–12 percent of people who receive a trabeculectomy will require a repeat procedure.
What is the prognosis of trabeculectomy? ›The failure rates in the trabeculectomy group were 13.9% at 1 year,28.2% at 2 years, and 30.7% at 3 years. Failure was defined as persistent hypotony (IOP less than or equal to 5mmHg) or IOP > 21mmHg or IOP not reduced by 20% below baseline.
Why do trabeculectomy fail? ›The main cause of a failed trabeculectomy is episcleral or subconjunctival fibrosis. When a trabeculectomy procedure fails and cannot be rescued, subsequent procedures include a second trabeculectomy, placement of an aqueous shunt, or a cyclodestructive procedure.