Hydrus® Microstent 신규 등록 승인 후 연구 (CONFIRM)
Hydrus® Microstent 신규 등록 승인 후 연구: 전향적, 비무작위, 다기관, 단일 암, 임상 시험
The purpose of this post-approval study is to evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae occurring within 24 months post-operation. Qualified subjects will undergo uncomplicated cataract surgery with placement of a monofocal intraocular lens (IOL), followed by implantation of the Hydrus Microstent.
연구 개요
상세 설명
Qualified subjects will attend a screening visit, a surgical visit (Day 0), and 8 scheduled postoperative visits at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24.
This study was initiated by Ivantis, Inc. Ivantis was acquired by Alcon Research, and Alcon assumed sponsorship of the study in November 2022.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Alcon Call Center
- 전화번호: 1-888-451-3937
- 이메일: alcon.medinfo@alcon.com
연구 장소
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California
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Irvine, California, 미국, 92618
- 완전한
- Coastal Vision
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Sacramento, California, 미국, 95815
- 모병
- Sacramento Eye Consultants
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Colorado
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Loveland, Colorado, 미국, 80538
- 모병
- Eye Center of Northern Colorado
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Iowa
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Sioux City, Iowa, 미국, 51104
- 모병
- Jones Eye Center PC
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Kansas
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Overland Park, Kansas, 미국, 66213
- 아직 모집하지 않음
- Stiles Eyecare Excellence Cataracts and Glaucoma
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Maryland
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Rockville, Maryland, 미국, 20852
- 아직 모집하지 않음
- Visionary Eye Doctors
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Michigan
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Fraser, Michigan, 미국, 48026
- 모병
- Fraser Eye Care Center
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Minnesota
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Coon Rapids, Minnesota, 미국, 55433
- 모병
- Twin Cities Eye Consultants
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Missouri
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Chesterfield, Missouri, 미국, 63017
- 모병
- Midwest Vision Research Foundation
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Kansas City, Missouri, 미국, 64154
- 아직 모집하지 않음
- Moyes Eye Center
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Nevada
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Las Vegas, Nevada, 미국, 89145
- 모병
- Center for Sight
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North Carolina
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Southern Pines, North Carolina, 미국, 28387
- 모병
- Carolina Eye Associates PA
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Ohio
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Brecksville, Ohio, 미국, 44141
- 완전한
- Cleveland Eye Clinic
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Cincinnati, Ohio, 미국, 45242
- 모병
- Cincinnati Eye Institute
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Mason, Ohio, 미국, 45040
- 아직 모집하지 않음
- Cincinnati Eye / Apex Eye
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Pennsylvania
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Cranberry Township, Pennsylvania, 미국, 16066
- 아직 모집하지 않음
- Scott & Christie and Associates, PC
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Texas
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Austin, Texas, 미국, 78731
- 모병
- Texan Eye / Keystone Research
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Dallas, Texas, 미국, 75231
- 아직 모집하지 않음
- Glaucoma Associates Of Texas
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El Paso, Texas, 미국, 79902
- 모병
- El Paso Eye Surgeons
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Hurst, Texas, 미국, 76054
- 모병
- Texas Eye Research Center
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Utah
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Salt Lake City, Utah, 미국, 84107
- 아직 모집하지 않음
- The Eye Institute of Utah
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Wisconsin
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Kenosha, Wisconsin, 미국, 53142
- 모병
- Eye Centers Of Racine And Kenosha
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- An operable, age-related cataract with best corrected visual acuity (BCVA) of 20/40 or worse;
- Diagnosis of primary open angle glaucoma treated with no more than 4 topical hypotensive medications;
- Optic nerve appearance characteristic of glaucoma;
- Medicated IOP less than or equal to 31 millimeters mercury (mmHg); Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Closed angle forms of glaucoma;
- Congenital or developmental glaucoma;
- Secondary glaucoma;
- Use of more than 4 ocular hypotensive medications;
- Previous argon laser trabeculoplasty, trabeculectomy, tube shunts, or any other prior filtration or cilioablative surgery;
- Prior surgery with implanted device or other surgery involving the trabecular meshwork or Schlemm's canal;
- Other protocol-defined exclusion criteria may apply.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Hydrus Microstent
Hydrus Microstent implanted in the eye immediately following cataract surgery and placement of a monofocal intraocular lens (IOL) |
Crescent-shaped nitinol device intended as a permanent implant to provide an outflow pathway for aqueous humor. The device is placed through the trabecular meshwork into Schlemm's canal immediately following placement of a monofocal IOL. Cataract surgery performed using standard anesthesia and phacoemulsification techniques Commercially available monofocal intraocular lens as determined by the investigator |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rate of occurrence of clinically significant device malposition associated with clinical sequelae
기간: Day 0 operative, up to Month 24 postoperative
|
The position of the implant will be assessed visually intraoperatively and at each postoperative follow-up visit. Examples of clinically significant device malposition associated with clinical sequelae as listed in the protocol include secondary surgical intervention to modify device position or to remove the device (explantation), corneal endothelial touch by device, iris touch by the device associated with intraocular inflammation, pigment dispersion or other sequelae, central endothelial cell loss ≥30 percent, compromised corneal function, best-corrected visual acuity (BCVA) loss of 2 lines (10 letters) or more on the ETDRS chart, device obstruction requiring secondary surgical intervention, persistent anterior chamber inflammation with peripheral anterior synechiae, persistent anterior chamber inflammation without peripheral anterior synechiae, and chronic pain. |
Day 0 operative, up to Month 24 postoperative
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rate of occurrence of intraoperative ocular adverse events
기간: Day 0 operative
|
Intraoperative ocular adverse events as specified in the protocol include hyphema obscuring the surgeon's view, choroidal hemorrhage or effusion, choroidal detachment, significant iris injury or trauma, corneal abrasion, corneal edema, zonular dialysis, cyclodialysis, cyclodialysis cleft, iridodialysis, vitreous loss not associated with the cataract procedure, inadvertent perforation of the sclera, and Descemet's membrane detachment. |
Day 0 operative
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|
Rate of occurrence of sight threatening postoperative adverse events
기간: Up to Month 24
|
Sight threatening, post-operative adverse events as specified in the protocol include endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment, and aqueous misdirection. |
Up to Month 24
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Rate of occurrence of other postoperative ocular adverse events
기간: Up to Month 24
|
Other postoperative ocular adverse events as specified in the protocol include anterior uveitis/iritis, non-persistent & persistent, best corrected visual acuity (BCVA) loss of 2 lines or more, chronic pain, device migration, device obstruction, peripheral anterior synechiae (PAS), ocular secondary surgical interventions for intraocular pressure (IOP) or glaucoma management, hypotony at or after 1 month postop, hyphema, corneal opacification, corneal edema persisting or severe corneal edema, other retinal complications, elevated mean IOP >/=10 millimeters mercury (mmHg) vs screening, iris prolapse/wound incarceration, significant foreign body sensation at or after 3 months postop, surgical re-intervention, and worsening of visual field. |
Up to Month 24
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Clinical Project Lead, CDMA Surgical, Alcon Research
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .