PEI-GT Trial for Initial Treatment of Primary Open-Angle Glaucoma With Cataract
2026년 7월 7일 업데이트: Nanfang Hospital, Southern Medical University
Efficacy and Safety of Phacoemulsification Combined With Gonioscopy-Assisted Trabeculotomy as Initial Treatment for Primary Open-Angle Glaucoma With Cataract: A Multicenter Randomized Controlled Trial
The goal of this clinical trial is to learn whether doing phacoemulsification combined with gonioscopy-assisted trabeculotomy as an initial treatment can reduce the burden of glaucoma eye drops in adults with primary open-angle glaucoma and cataract. It will also learn whether this early surgical strategy improves ocular surface health and vision-related quality of life. The main questions it aims to answer are:
Does early combined surgery reduce the need for long-term glaucoma medications? Does early combined surgery improve ocular surface health compared with cataract surgery followed by guideline-based glaucoma eye drops? Does early combined surgery improve vision-related quality of life and anxiety compared with the medication-based treatment strategy? What medical problems or complications do participants have after treatment? Researchers will compare phacoemulsification combined with gonioscopy-assisted trabeculotomy to phacoemulsification followed by guideline-based topical eye pressure-lowering medications.
Participants will:
Undergo cataract surgery with or without gonioscopy-assisted trabeculotomy Attend follow-up visits for 24 months after treatment Have eye pressure, visual acuity, OCT, AS-OCT, visual field, ocular surface, and safety examinations at scheduled visits Complete quality-of-life and anxiety questionnaires at scheduled visits Provide tear samples at selected visits for biomarker testing where applicable
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Primary open-angle glaucoma is a chronic progressive optic neuropathy in which sustained intraocular pressure control is important for delaying structural and functional progression.
Long-term topical IOP-lowering medication may be limited by ocular surface disease, poor adherence, treatment cost, and cumulative ocular tissue exposure.
Gonioscopy-assisted trabeculotomy is an ab interno minimally invasive glaucoma procedure that can be combined with phacoemulsification in patients with coexisting cataract.
This trial will compare PEI plus GT with PEI plus conventional medications as an initial treatment strategy in treatment-naive patients with POAG and cataract.
Randomization will be stratified by center and implemented through an IWRS or equivalent web-based randomization system.
Outcome assessors will be masked whenever feasible.
Follow-up visits are scheduled at Day 1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
106
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Hongyang Zhang, PhD
- 전화번호: +86-20-62787325
- 이메일: hy3005716@163.com
연구 연락처 백업
- 이름: Yuqiao Zhang, PhD
- 이메일: yqzhang@link.cuhk.edu.hk
연구 장소
-
-
-
Guangzhou, 중국
- 모병
- Nanfang Hospital, Southern Medical University
-
연락하다:
- Hongyang Zhang
- 전화번호: +86-20-62787325
- 이메일: hy3005716@163.com
-
Luzhou, 중국
- 아직 모집하지 않음
- The Affiliated Hospital of Southwest Medical University
-
Zhengzhou, 중국
- 아직 모집하지 않음
- The First Affiliated Hospital of Zhengzhou University
-
연락하다:
- Xin Yang
-
Zhuhai, 중국
- 아직 모집하지 않음
- Zhuhai Hospital of Guangdong Provincial Hospital of Chinese Medicine
-
-
Ningxia
-
Ningxia, Ningxia, 중국
- 아직 모집하지 않음
- People's Hospital of Ningxia Hui Autonomous Region
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Provides written informed consent voluntarily.
- Age 40 to 85 years.
- Male or female.
- Treatment-naive for glaucoma, with no prior IOP-lowering medication, glaucoma laser procedure, or glaucoma surgery.
- Lens opacity causing decreased visual quality and clinically significant cataract.
- Diagnosis of POAG combined with cataract by the treating ophthalmologist.
- Best-corrected visual acuity of 0.1 or better on the Snellen chart, corresponding to LogMAR 1.0 or less.
- Ability and willingness to complete scheduled follow-up visits and study examinations.
Exclusion Criteria:
- Secondary glaucoma, including uveitic, pseudoexfoliative, pigmentary, steroid-induced, neovascular, traumatic, or other secondary glaucoma.
- Angle-closure glaucoma or narrow angle inconsistent with POAG.
- POAG without visually significant cataract.
- Previous anti-glaucoma medication use, glaucoma surgery, or glaucoma laser treatment.
- Advanced visual field loss, defined as visual field mean deviation worse than -12 dB.
- Severe ocular comorbidity or inability to perform reliable visual acuity testing.
- Known contraindication to required study medications.
- Average RNFL thickness or GCIPL thickness less than 54 micrometers.
- Axial length greater than 26 mm.
- Monocular status or functional vision in only one eye.
- Inability to complete reliable visual field or OCT testing.
- Systemic disease that may affect ocular status or study assessment, including diabetes mellitus, uncontrolled hypertension, malignancy, renal disease, autoimmune disease, neurological disease, liver disease, cardiovascular disease, or systemic inflammatory disease.
- Visual impairment mainly attributable to disease other than POAG or cataract.
- Pregnancy, lactation, or planned pregnancy during the study period.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: PEI combined with gonioscopy-assisted trabeculotomy
Participants will undergo phacoemulsification cataract extraction with intraocular lens implantation combined with approximately 120 degrees of ab interno gonioscopy-assisted trabeculotomy during the same surgical session.
Postoperative care will follow the protocol, and rescue IOP-lowering medications may be added if clinically indicated.
|
Phacoemulsification combined with Ab interno trabeculotomy performed under gonioscopic visualization for approximately 120 degrees to incise/open the trabecular meshwork and expose Schlemm canal.
The cutting instrument will be non-device-dependent, such as a Tanito hook, Lanxin knife, Zeng knife, or bent 25-26G needle; KDB is not included as the cutting blade.
|
|
활성 비교기: PEI combined with conventional IOP-lowering medications
Participants will undergo phacoemulsification cataract extraction with intraocular lens implantation.
Postoperatively, conventional topical IOP-lowering medications will be initiated or adjusted according to guideline-based care and clinical judgment when IOP remains above target.
|
Phacoemulsification combined with guideline-based topical IOP-lowering therapy, generally including prostaglandin analogues unless contraindicated, with beta-blockers, carbonic anhydrase inhibitors, alpha-2 agonists, or other agents added or adjusted according to efficacy, tolerance, contraindications, and clinical judgment.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean change in intraocular pressure from baseline to Month 24
기간: Baseline and Month 24
|
Intraocular pressure will be measured in mmHg, preferably by Goldmann applanation tonometry.
Change will be calculated as Month 24 IOP minus baseline IOP and compared between groups.
|
Baseline and Month 24
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Complete success rate
기간: Month 24
|
Proportion of participants achieving postoperative IOP >5 mmHg and ≤16 mmHg or at least 20 percent IOP reduction from baseline, without additional IOP-lowering medication, without vision-threatening complication, and without additional glaucoma surgery.
|
Month 24
|
|
Qualified success rate
기간: Month 24
|
Proportion of participants achieving postoperative IOP >5 mmHg and ≤16 mmHg or at least 20 percent IOP reduction from baseline, with or without IOP-lowering medication, without vision-threatening complication, and without additional glaucoma surgery.
|
Month 24
|
|
Number of IOP-lowering medications
기간: Baseline, Day 1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
|
Number and class of topical IOP-lowering medications used at each follow-up visit.
|
Baseline, Day 1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
|
|
Best-corrected visual acuity
기간: Baseline through Month 24
|
Best-corrected visual acuity will be recorded and converted to LogMAR for analysis.
|
Baseline through Month 24
|
|
Visual field indices
기간: Baseline, Month 6, Month 12, Month 18, and Month 24
|
Humphrey visual field 30-2 SITA Standard indices, including mean deviation and pattern standard deviation, will be recorded with reliability criteria.
|
Baseline, Month 6, Month 12, Month 18, and Month 24
|
|
Retinal nerve fiber layer thickness
기간: Baseline, Month 6, Month 12, Month 18, and Month 24
|
Peripapillary retinal nerve fiber layer thickness will be measured by OCT.
|
Baseline, Month 6, Month 12, Month 18, and Month 24
|
|
Ganglion cell-inner plexiform layer thickness
기간: Baseline, Month 6, Month 12, Month 18, and Month 24
|
Macular ganglion cell-inner plexiform layer thickness will be measured by OCT.
|
Baseline, Month 6, Month 12, Month 18, and Month 24
|
|
Anterior segment parameters by AS-OCT
기간: Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
|
AS-OCT parameters may include anterior chamber depth, angle opening distance, trabecular-iris space area, and other protocol-specified anterior segment findings.
|
Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
|
|
Ocular surface parameters
기간: Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
|
Ocular surface assessment includes lipid layer thickness, tear meniscus height, non-invasive tear break-up time, meibomian gland structure, conjunctival hyperemia, and corneal fluorescein staining.
|
Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
|
|
NEI VFQ-25 score
기간: Baseline, Month 6, Month 12, Month 18, and Month 24
|
Vision-related quality of life will be assessed using the National Eye Institute Visual Function Questionnaire-25 total score.
|
Baseline, Month 6, Month 12, Month 18, and Month 24
|
|
GAD-7 score
기간: Baseline, Month 6, Month 12, Month 18, and Month 24
|
Anxiety will be assessed using the Generalized Anxiety Disorder 7-item scale total score.
|
Baseline, Month 6, Month 12, Month 18, and Month 24
|
|
Incidence of adverse events
기간: Day 1 through Month 24
|
Ocular and systemic adverse events and serious adverse events will be recorded, including IOP spike, hypotony, hyphema, corneal edema, anterior chamber inflammation, posterior capsule opacification, infection, and need for additional glaucoma surgery.
|
Day 1 through Month 24
|
|
Health economic indicators
기간: Baseline through Month 24
|
Direct medical costs, medication costs, follow-up costs, complication management costs, and other prespecified economic cost indicators will be summarized.
|
Baseline through Month 24
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Tear-fluid biomarker levels
기간: Baseline and Month 24
|
Tear-fluid biomarkers include matrix metalloproteinase (MMP), interleukin-13 (IL-13), and tumor necrosis factor-alpha (TNF-alpha).
|
Baseline and Month 24
|
|
Surgery-drug benefit index
기간: Baseline through Month 24
|
Composite exploratory index integrating IOP control, medication reduction, structural preservation, ocular surface status, quality of life, safety, and economic outcomes.
|
Baseline through Month 24
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 7월 15일
기본 완료 (추정된)
기본 완료
2029년 12월 31일
연구 완료 (추정된)
연구 완료
2030년 12월 31일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 7일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 7일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 14일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 7일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- NFEC-2026-303
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .