None listed
Conditions
Brief summary
In Australia, high-volume private refractive clinics are presented with OHT and OAG patients suitable for iStent technologies; however, most implantation cases occur in glaucoma specialist settings. A published study from a reputable refractive surgical centre in Sydney that demonstrates iStent inject combined with cataract surgery led to improved visual acuity along with intraocular pressure (IOP) or topical IOP-lowering medication reductions in open-angle glaucoma (OAG) eyes with a cataract comorbidity. A similar or improved result with iStent infinite may help drive adoption from other similar clinics in the country. Furthermore, the potential for reducing glaucoma medication burden in patients may also alleviate dry eye disease, thus further improving patients’ quality of life and minimizing out-of-pocket expenses.
Interventions
iStent infinite and dry eye reduction in ocular hypertension (OHT) and open angle glaucoma (OAG) patients with premium intraocular lenses (IOL)
Participants are adult patients with OHT or mild-to-moderate (greater than or equal to 12 dB) controlled OAG and topical glaucoma medication-associated dry eyes planned for cataract surgery or who have had prior premium IOL implantation who are willing to be followed up to 24 months postoperative and the following inclusion criteria pertaining to dry ey
iStent infinite and dry eye reduction in ocular hypertension (OHT) and open angle glaucoma (OAG) patients with premium intraocular lenses (IOL) Participants are adult patients with OHT or mild-to-moderate (greater than or equal to 12 dB) controlled OAG and topical glaucoma medication-associated dry eyes planned for cataract surgery or who have had prior premium IOL implantation who are willing to be followed up to 24 months postoperative and the following inclusion criteria pertaining to dry eye: 1. Cataract surgery alone (20mins by ophthalmologist) Standard phacoemulsification will be performed through a temporal clear corneal incision, and a foldable intraocular lens implanted in the posterior capsule of all eyes. Under topical or sub-Tenon's anaesthesia dependent on patient preference. 2. iStent infinite alone (10mins by ophthalmologist) Pre-op pupil constriction with Pilocarpine 2% x3 instillations iStent infinite implantation will consist of these steps: through a single temporal peripheral clear corneal incision, after filling the anterior chamber with viscoelastic, the iStent infinite injector will be advanced under direct gonioscopy to the nasal trabecular meshwork, where the first stent will be implanted through the meshwork into Schlemm’s canal. The injector tip will be repositioned to implant the second stent ~2 clock-hours away from the first stent. The third stent will be implanted using the same procedure as the previous stents, placing the implant ~2 clock hours away from either of the first 2 stents. To ensure optimal positioning and angle of approach, the surgeon may choose to exit the eye and reposition after the first or second stent implant. After insertion of the 3 stents, proper placement and seating in the trabecular meshwork will be confirmed under intraoperative gonioscopy. [record stents are minimum 2 clock-hours apart] Viscoelastic will be removed and sealing of the corneal incision will be ensured. 3. iStent infinite combo procedure (30 mins by ophthalmologist) Stents will be placed at the end of cataract surgery. Procedural records will be kept to monitor adherence to the intervention
Sponsors
Glaukos Corporation
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Adult patients with OHT or mild-to-moderate (greater than or equal to 12 dB) controlled OAG and topical glaucoma medication-associated dry eyes planned for cataract surgery or who have had prior premium intraocular lens (IOL) implantation who are willing to be followed up to 24 months postoperatively
Exclusion criteria
: History of incisional glaucoma surgery, argon laser trabeculoplasty, iridectomy, or iridotomy, or completion of selective laser trabeculoplasty within 90 days before screening
Outcome results
None listed