Implantation of Capsular Tension Ring in Primary Angle Closure Patients With Zonular Laxity or Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Spherical equivalent
研究概览
简要总结
Primary angle closure glaucoma (PACG) is the main type of glaucoma in China, which includes acute and chronic PACG. According to the International Society of Geographical and Epidemiological Ophthalmology (ISGEO), this spectrum of disease is divided into acute angle closure crisis (AACC), primary angle closure suspect (PACS), primary angle closure (PAC) and PACG. Previous researchers have reported that with the wider use of lens extraction and intraocular lens (IOL) implantation combined with anti-glaucoma surgery in the treatment of PAC and PACG, the prevalence of zonular laxity or dialysis in primary angle closure disease (PACD) was found to be relatively high. In one of the studies performed by the investigators, the proportion of zonular laxity or dialysis was 46.2%, significantly higher than that in the age-related cataract patients (control group), which was 6.0%. In PACD patients with zonular laxity or dialysis, whether or not should the investigators implant capsular tension ring (CTR), the efficacy and safety of CTR implantation, and if there is any difference in the prevalence of complications during and after surgery between patients with and without CTR implantation remain unclear. The purpose of this study was to investigate the efficacy and safety of CTR implantation in PACD patients with zonular laxity and zonular dialysis ≤ 4 clocks.
详细描述
Patients with PACD who are scheduled to have phacoemulsification and IOL implantation combined with goniosynechialysis are recruited. All recruited patients attended comprehensive eye examinations and interviews. Past history of ocular and systemic diseases, family and personal history, history of ocular trauma and surgery were interviewed. And the patients underwent ophthalmic examinations including visual acuity tests (presenting visual acuity [PVA] and best-corrected visual acuity [BCVA]), subjective refraction, intraocular pressure (IOP) measurements, slit-lamp examination, fundus photography, gonioscopy, ocular biometry using IOL Master 700, ultrasound biomicroscopy, anterior segment optical coherence tomography (ASOCT) imaging. All patients provide informed consent for inclusion in the study.
All surgery procedures were performed by the same surgeons (CYQ) using the same standard operation procedure. All patients use the same type of foldable IOL calculated using SRK/T formula. During the surgery, patients with wrinkling of the anterior capsule (multiple sinusoidal folds were formed) during continuous curvilineal capsulorhexis (CCC) at the needle or forceps tip but without infolding of peripheral capsule or visualisation of the capsular equator during the cortical or nuclear removal, or, wrinkling of the anterior capsule during CCC with infolding of peripheral capsule and visualisation of the capsular equator ≤ 4 clocks of range during the cortical or nuclear removal, were finally included in the study and randomly assigned (using a random-number table generated by SAS) with equal probability to either CTR group (with CTR implantation during the surgery) and control group (without CTR implantation during the surgery). All patients included in the CTR group use the same type of CTR. The investigators recorded the complications during the surgery including vitreous prolapse, hyphema, vitreous hemorrhage, damage of iris and lens capsule, et al.
Postoperatively, all patients received similar routine medication comprising topical prednisolone acetate (six times a day for 1 week and tapered down by 1 time every week), topical levofloxacin hydrochloride (four times a day for 1 month), and Tobramycin and Dexamethasone Eye Ointment (1 time every night for 1 month).
Postoperative examinations were performed at 1 day, 1 week, 1 months, 3 months, 6 months and 12 months. During the follow-up visits, a complete ophthalmic examination was performed including PVA, BCVA, subjective refraction, non-contact IOP measurement, slit-lamp examination, slit-lamp photography after pupil dilation, ASOCT, gonioscopy, and fundus imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 45-79 years old
- •Continuous cases diagnosed with AACC, PACS, PAC and PACG in glaucoma department of Beijing Tongren Hospital from October 1st, 2022 to December 31th, 2024 and undergo phacoemulsification lens extraction and intraocular lens implantation combined with goniosynechialysis
- •Wrinkling of the anterior capsule during manual continuous circular capsulorhexis (CCC) but without infolding of peripheral capsule or visualization of the capsular equator, or, wrinkling of the anterior capsule during manual capsulorhexis and combined with visualization of capsular equator and infolding of peripheral capsule ≤ 4 clocks (lens subluxation)
- •The eye of each subject that meet the inclusion criteria is included and if both eyes meet the inclusion criteria, the first eye that undergo the surgery is included
排除标准
- •Past history of intraocular surgeries including trabeculectomy, peripheral iridotomy, glaucoma valve implantation, vitrectomy, and so on
- •Past history of laser peripheral iridotomy or iridoplasty
- •Past history of ocular trauma or signs referring to ocular trauma
- •Ocular diseases that may cause zonulopathy, including choroidal detachment, retinal detachment, ciliary body detachment, intraocular tumor and so on
- •Lens related secondary glaucoma, including spherophakia, Marfan syndrome, homocystinuria and son on
- •Other secondary angle closure glaucoma, including neovascular glaucoma, iritis related secondary glaucoma and so on
- •Visualization of capsular equator and infolding of peripheral capsule > 4 clocks during the surgery
- •Anterior or posterior capsule rupture during the surgery which makes it impossible for CTR implantation
结局指标
主要结局
Spherical equivalent
时间窗: 12 months after the surgery
Sphere +1/2 cylinder obtained from subjective refraction
Area of anterior capsulorhexis
时间窗: 12 months after the surgery
Area of anterior capsulorhexis measured using slit-lamp photography
Assessment of posterior capsular opacification
时间窗: 12 months after the surgery
Assessment of posterior capsular opacification using slit-lamp photography
The extent of peripheral anterior synechia
时间窗: 12 months after the surgery
The extent of peripheral anterior synechia assessed by gonioscopy
Refractive prediction error
时间窗: baseline
Refractive prediction error obtained by IOL Master 700
Anterior chamber depth
时间窗: 12 months after the surgery
Anterior chamber depth obtained by anterior segment optical coherence tomography
Angle opening distance
时间窗: 12 months after the surgery
Angle opening distance obtained by anterior segment optical coherence tomography
Trabecular-iris angle
时间窗: 12 months after the surgery
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Anterior chamber width
时间窗: 12 months after the surgery
Anterior chamber width obtained by anterior segment optical coherence tomography
Intraocular lens inclination angle
时间窗: 12 months after the surgery
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
The distance between ciliary body and the equator of lens at 3 o'clock position
时间窗: baseline
The distance between ciliary body and the equator of lens at 3 o'clock position obtained by ultrasound biomicroscopy
Lens thickness
时间窗: 12 months after the surgery
Lens thickness obtained by anterior segment optical coherence tomography
Trabecular-iris space area
时间窗: 12 months after the surgery
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Iris cross-sectional area
时间窗: 12 months after the surgery
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Iris curvature
时间窗: 12 months after the surgery
Iris curvature obtained by anterior segment optical coherence tomography
Lens vault
时间窗: 12 months after the surgery
Lens vault obtained by anterior segment optical coherence tomography
The extent of iris-trabecular contact
时间窗: 12 months after the surgery
The extent of iris-trabecular contact assessed by gonioscopy
Corneal thickness
时间窗: baseline
Corneal thickness obtained by IOL Master 700
Effective intraocular lens position
时间窗: 12 months after the surgery
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
The distance between ciliary body and the equator of lens at 9 o'clock position
时间窗: baseline
The distance between ciliary body and the equator of lens at 9 o'clock position obtained by ultrasound biomicroscopy
The distance between ciliary body and the equator of lens at 12 o'clock position
时间窗: baseline
The distance between ciliary body and the equator of lens at 12 o'clock position obtained by ultrasound biomicroscopy
Central anterior chamber depth
时间窗: baseline
Central anterior chamber depth obtained by IOL Master 700
Axial Length
时间窗: baseline
Axial Length obtained by IOL Master 700
Iris thickness
时间窗: 12 months after the surgery
Iris thickness obtained by anterior segment optical coherence tomography
The distance between intraocular lens and the posterior capsular
时间窗: 12 months after the surgery
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
The distance between ciliary body and the equator of lens at 6 o'clock position
时间窗: baseline
The distance between ciliary body and the equator of lens at 6 o'clock position obtained by ultrasound biomicroscopy
Incidence of complications
时间窗: 12 months after the surgery
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
次要结局
- Presenting visual acuity(12 months after the surgery)
- Number of anti-glaucoma medications(12 months after the surgery)
- Best corrected visual acuity(12 months after the surgery)
- Intraocular pressure(12 months after the surgery)
- Vertical cup-to-disc ratio(12 months after the surgery)
研究者
Chunyan Qiao_2021
Ophthalmologist, Professor, M.D.
Beijing Tongren Hospital