36-Month Outcomes from the Prospective GEMINI Study: Canaloplasty and Trabeculotomy Combined with Cataract Surgery for Patients with Primary Open-Angle Glaucoma
Michael D Greenwood,1 Arkadiy Yadgarov,2 Brian E Flowers,3 Steven R Sarkisian Jr,4 Afua Ohene-Nyako,5 Jaime E Dickerson Jr5,6 On behalf of the GEMINI 2 STUDY GROUP1Vance Thompson Vision, West Fargo, ND, USA; 2Omni Eye Services, Atlanta, GA, USA; 3Ophthalmology Associates, Fort Worth, TX, USA; 4Oklah...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2023-12-01
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| Series: | Clinical Ophthalmology |
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| Online Access: | https://www.dovepress.com/36-month-outcomes-from-the-prospective-gemini-study-canaloplasty-and-t-peer-reviewed-fulltext-article-OPTH |
| _version_ | 1797391157194391552 |
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| author | Greenwood MD Yadgarov A Flowers BE Sarkisian Jr SR Ohene-Nyako A Dickerson jr JE |
| author_facet | Greenwood MD Yadgarov A Flowers BE Sarkisian Jr SR Ohene-Nyako A Dickerson jr JE |
| author_sort | Greenwood MD |
| collection | DOAJ |
| description | Michael D Greenwood,1 Arkadiy Yadgarov,2 Brian E Flowers,3 Steven R Sarkisian Jr,4 Afua Ohene-Nyako,5 Jaime E Dickerson Jr5,6 On behalf of the GEMINI 2 STUDY GROUP1Vance Thompson Vision, West Fargo, ND, USA; 2Omni Eye Services, Atlanta, GA, USA; 3Ophthalmology Associates, Fort Worth, TX, USA; 4Oklahoma Eye Surgeons, Oklahoma City, OK, USA; 5Sight Sciences, Menlo Park, CA, USA; 6North Texas Eye Research Institute, University of North Texas Health Science Center, Fort Worth, TX, USACorrespondence: Jaime E Dickerson, Email Jaime.dickerson@unthsc.eduPurpose: To provide long-term intraocular pressure (IOP) and ocular hypotensive medication usage outcomes through 36 months for patients treated with canaloplasty and trabeculotomy (OMNI Surgical System) combined with cataract surgery as participants in the GEMINI study.Setting: Eleven ophthalmology practices in 10 US states.Design: Non-interventional 36-month extension of the 12-month, prospective, multicenter, GEMINI study.Methods: GEMINI patients had visually significant cataract, mild-to-moderate glaucoma (ICD-10 guidelines), medicated IOP < 33 mmHg, and unmedicated mean diurnal IOP (DIOP) (after washout) 21– 36 mmHg. Patients from GEMINI were eligible for inclusion. Outcome measures were reduction in mean unmedicated DIOP, reduction in mean IOP-lowering medications, percent of eyes with ≥ 20% reduction in unmedicated DIOP, and percent of eyes with unmedicated DIOP ≥ 6 and ≤ 18 mmHg.Results: A total of 66 patients provided consent and were enrolled. Mean (SD) unmedicated DIOP was 23.1 (2.7) mmHg at baseline, 16.7 (4.1), 16.3 (3.3) at 24 and 36 months; mean reductions of 6.2 (4.1) and 6.9 (3.4) mmHg. Twelve-month IOP at the end of GEMINI was 15.6 mmHg. The proportion of eyes with ≥ 20% reduction in IOP was 77% and 78% (months 24 and 36) compared to 87% at month 12 from GEMINI. About 68% of patients had an IOP between 6 and 18 mmHg at 24 months and 71% at 36 months. Mean IOP-lowering medications was 1.7 at baseline, which was reduced to 0.4 (24 months, − 1.3) and 0.3 (36 months, − 1.4). About 74% of patients (46 of 62) were medication free at 36 months.Conclusion: GEMINI demonstrated 12-month effectiveness of canaloplasty and trabeculotomy with OMNI combined with cataract surgery for IOP and medication reduction in mild-to-moderate glaucoma. However, longer-term data is key to the decision making in the selection of a surgical treatment. This GEMINI extension demonstrates that the 12-month outcomes from GEMINI were sustained through 36 months.Keywords: canaloplasty, trabeculotomy, MIGS, OMNI, glaucoma |
| first_indexed | 2024-03-08T23:28:59Z |
| format | Article |
| id | doaj.art-86f71d60561248f3a85b60ec8c3a26f1 |
| institution | Directory Open Access Journal |
| issn | 1177-5483 |
| language | English |
| last_indexed | 2024-03-08T23:28:59Z |
| publishDate | 2023-12-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Clinical Ophthalmology |
| spelling | doaj.art-86f71d60561248f3a85b60ec8c3a26f12023-12-14T17:01:44ZengDove Medical PressClinical Ophthalmology1177-54832023-12-01Volume 17381738248895636-Month Outcomes from the Prospective GEMINI Study: Canaloplasty and Trabeculotomy Combined with Cataract Surgery for Patients with Primary Open-Angle GlaucomaGreenwood MDYadgarov AFlowers BESarkisian Jr SROhene-Nyako ADickerson jr JEMichael D Greenwood,1 Arkadiy Yadgarov,2 Brian E Flowers,3 Steven R Sarkisian Jr,4 Afua Ohene-Nyako,5 Jaime E Dickerson Jr5,6 On behalf of the GEMINI 2 STUDY GROUP1Vance Thompson Vision, West Fargo, ND, USA; 2Omni Eye Services, Atlanta, GA, USA; 3Ophthalmology Associates, Fort Worth, TX, USA; 4Oklahoma Eye Surgeons, Oklahoma City, OK, USA; 5Sight Sciences, Menlo Park, CA, USA; 6North Texas Eye Research Institute, University of North Texas Health Science Center, Fort Worth, TX, USACorrespondence: Jaime E Dickerson, Email Jaime.dickerson@unthsc.eduPurpose: To provide long-term intraocular pressure (IOP) and ocular hypotensive medication usage outcomes through 36 months for patients treated with canaloplasty and trabeculotomy (OMNI Surgical System) combined with cataract surgery as participants in the GEMINI study.Setting: Eleven ophthalmology practices in 10 US states.Design: Non-interventional 36-month extension of the 12-month, prospective, multicenter, GEMINI study.Methods: GEMINI patients had visually significant cataract, mild-to-moderate glaucoma (ICD-10 guidelines), medicated IOP < 33 mmHg, and unmedicated mean diurnal IOP (DIOP) (after washout) 21– 36 mmHg. Patients from GEMINI were eligible for inclusion. Outcome measures were reduction in mean unmedicated DIOP, reduction in mean IOP-lowering medications, percent of eyes with ≥ 20% reduction in unmedicated DIOP, and percent of eyes with unmedicated DIOP ≥ 6 and ≤ 18 mmHg.Results: A total of 66 patients provided consent and were enrolled. Mean (SD) unmedicated DIOP was 23.1 (2.7) mmHg at baseline, 16.7 (4.1), 16.3 (3.3) at 24 and 36 months; mean reductions of 6.2 (4.1) and 6.9 (3.4) mmHg. Twelve-month IOP at the end of GEMINI was 15.6 mmHg. The proportion of eyes with ≥ 20% reduction in IOP was 77% and 78% (months 24 and 36) compared to 87% at month 12 from GEMINI. About 68% of patients had an IOP between 6 and 18 mmHg at 24 months and 71% at 36 months. Mean IOP-lowering medications was 1.7 at baseline, which was reduced to 0.4 (24 months, − 1.3) and 0.3 (36 months, − 1.4). About 74% of patients (46 of 62) were medication free at 36 months.Conclusion: GEMINI demonstrated 12-month effectiveness of canaloplasty and trabeculotomy with OMNI combined with cataract surgery for IOP and medication reduction in mild-to-moderate glaucoma. However, longer-term data is key to the decision making in the selection of a surgical treatment. This GEMINI extension demonstrates that the 12-month outcomes from GEMINI were sustained through 36 months.Keywords: canaloplasty, trabeculotomy, MIGS, OMNI, glaucomahttps://www.dovepress.com/36-month-outcomes-from-the-prospective-gemini-study-canaloplasty-and-t-peer-reviewed-fulltext-article-OPTHcanaloplastytrabeculotomymigsomniglaucoma |
| spellingShingle | Greenwood MD Yadgarov A Flowers BE Sarkisian Jr SR Ohene-Nyako A Dickerson jr JE 36-Month Outcomes from the Prospective GEMINI Study: Canaloplasty and Trabeculotomy Combined with Cataract Surgery for Patients with Primary Open-Angle Glaucoma Clinical Ophthalmology canaloplasty trabeculotomy migs omni glaucoma |
| title | 36-Month Outcomes from the Prospective GEMINI Study: Canaloplasty and Trabeculotomy Combined with Cataract Surgery for Patients with Primary Open-Angle Glaucoma |
| title_full | 36-Month Outcomes from the Prospective GEMINI Study: Canaloplasty and Trabeculotomy Combined with Cataract Surgery for Patients with Primary Open-Angle Glaucoma |
| title_fullStr | 36-Month Outcomes from the Prospective GEMINI Study: Canaloplasty and Trabeculotomy Combined with Cataract Surgery for Patients with Primary Open-Angle Glaucoma |
| title_full_unstemmed | 36-Month Outcomes from the Prospective GEMINI Study: Canaloplasty and Trabeculotomy Combined with Cataract Surgery for Patients with Primary Open-Angle Glaucoma |
| title_short | 36-Month Outcomes from the Prospective GEMINI Study: Canaloplasty and Trabeculotomy Combined with Cataract Surgery for Patients with Primary Open-Angle Glaucoma |
| title_sort | 36 month outcomes from the prospective gemini study canaloplasty and trabeculotomy combined with cataract surgery for patients with primary open angle glaucoma |
| topic | canaloplasty trabeculotomy migs omni glaucoma |
| url | https://www.dovepress.com/36-month-outcomes-from-the-prospective-gemini-study-canaloplasty-and-t-peer-reviewed-fulltext-article-OPTH |
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