Early postoperative safety and surgical outcomes after implantation of a suprachoroidal micro-stent for the treatment of open-angle glaucoma concomitant with cataract surgery

Helmut Hoeh, Iqbal Ike K Ahmed, Swaantje Grisanti, Salvatore Grisanti, Günther Grabner, Quang H. Nguyen, Magda Rau, Sonia H Yoo, Tsontcho Ianchulev

Research output: Contribution to journalArticle

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Abstract

Purpose: To evaluate the safety of a new suprachoroidal device, the Cypass micro-stent, for the surgical treatment of open-angle glaucoma (OAG) implanted in conjunction with cataract surgery. Setting: Multicenter clinical study. Design: Prospective interventional case series. Methods: This is an interim report of an ongoing safety study. Patients with OAG glaucoma (Shaffer grade 3 and 4) who were also candidates for cataract surgery in the affected eye had standard phacoemulsification followed by micro-stent implantation in the supraciliary space. Included were patients with uncontrolled (≥21 mm Hg, Cohort 1) or controlled (<21 mm Hg, Cohort 2) medicated intraocular pressure (IOP) at baseline. Glaucoma medications were discontinued at surgery and resumed at the discretion of each investigator. Measures included adverse events/complications and postoperative changes in IOP or medication. Results: The mean baseline medicated IOP was 21.1 mm Hg ± 5.91 (SD); the mean number of IOP-lowering medications was 2.1 ± 1.1 (N = 184). There were no major events such as retinal or choroidal detachment or endophthalmitis. The most common complications were transient early hypotony (13.8%) and transient IOP increase (10.5%). Uncontrolled patients (n = 57) had a 37% IOP reduction (P<.001), with more than a 50% reduction in glaucoma medications at 6 months (P<.001). Intraocular pressure-controlled patients (n = 41) had a 71.4% reduction in glaucoma medications (P<.001). Conclusion: Initial clinical experience with the new micro-stent showed a low rate of surgical complications with concomitant decreases in IOP and/or glaucoma medications. Financial Disclosure: Drs. Hoeh, Ahmed, Swaantje Grisanti, Salvatore Grisanti, Grabner, Nguyen, Rau, and Yoo are clinical investigators for Transcend Medical; Dr. Ahmed is a consultant to Transcend Medical; Dr. Ianchulev is an employee of Transcend Medical.

Original languageEnglish
Pages (from-to)431-435
Number of pages5
JournalJournal of Cataract and Refractive Surgery
Volume39
Issue number3
DOIs
StatePublished - Mar 1 2013

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Open Angle Glaucoma
Intraocular Pressure
Cataract
Stents
Safety
Glaucoma
Therapeutics
Research Personnel
Endophthalmitis
Phacoemulsification
Disclosure
Consultants
Multicenter Studies
Equipment and Supplies

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems
  • Surgery

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Early postoperative safety and surgical outcomes after implantation of a suprachoroidal micro-stent for the treatment of open-angle glaucoma concomitant with cataract surgery. / Hoeh, Helmut; Ahmed, Iqbal Ike K; Grisanti, Swaantje; Grisanti, Salvatore; Grabner, Günther; Nguyen, Quang H.; Rau, Magda; Yoo, Sonia H; Ianchulev, Tsontcho.

In: Journal of Cataract and Refractive Surgery, Vol. 39, No. 3, 01.03.2013, p. 431-435.

Research output: Contribution to journalArticle

Hoeh, Helmut ; Ahmed, Iqbal Ike K ; Grisanti, Swaantje ; Grisanti, Salvatore ; Grabner, Günther ; Nguyen, Quang H. ; Rau, Magda ; Yoo, Sonia H ; Ianchulev, Tsontcho. / Early postoperative safety and surgical outcomes after implantation of a suprachoroidal micro-stent for the treatment of open-angle glaucoma concomitant with cataract surgery. In: Journal of Cataract and Refractive Surgery. 2013 ; Vol. 39, No. 3. pp. 431-435.
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AU - Ahmed, Iqbal Ike K

AU - Grisanti, Swaantje

AU - Grisanti, Salvatore

AU - Grabner, Günther

AU - Nguyen, Quang H.

AU - Rau, Magda

AU - Yoo, Sonia H

AU - Ianchulev, Tsontcho

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N2 - Purpose: To evaluate the safety of a new suprachoroidal device, the Cypass micro-stent, for the surgical treatment of open-angle glaucoma (OAG) implanted in conjunction with cataract surgery. Setting: Multicenter clinical study. Design: Prospective interventional case series. Methods: This is an interim report of an ongoing safety study. Patients with OAG glaucoma (Shaffer grade 3 and 4) who were also candidates for cataract surgery in the affected eye had standard phacoemulsification followed by micro-stent implantation in the supraciliary space. Included were patients with uncontrolled (≥21 mm Hg, Cohort 1) or controlled (<21 mm Hg, Cohort 2) medicated intraocular pressure (IOP) at baseline. Glaucoma medications were discontinued at surgery and resumed at the discretion of each investigator. Measures included adverse events/complications and postoperative changes in IOP or medication. Results: The mean baseline medicated IOP was 21.1 mm Hg ± 5.91 (SD); the mean number of IOP-lowering medications was 2.1 ± 1.1 (N = 184). There were no major events such as retinal or choroidal detachment or endophthalmitis. The most common complications were transient early hypotony (13.8%) and transient IOP increase (10.5%). Uncontrolled patients (n = 57) had a 37% IOP reduction (P<.001), with more than a 50% reduction in glaucoma medications at 6 months (P<.001). Intraocular pressure-controlled patients (n = 41) had a 71.4% reduction in glaucoma medications (P<.001). Conclusion: Initial clinical experience with the new micro-stent showed a low rate of surgical complications with concomitant decreases in IOP and/or glaucoma medications. Financial Disclosure: Drs. Hoeh, Ahmed, Swaantje Grisanti, Salvatore Grisanti, Grabner, Nguyen, Rau, and Yoo are clinical investigators for Transcend Medical; Dr. Ahmed is a consultant to Transcend Medical; Dr. Ianchulev is an employee of Transcend Medical.

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