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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
156
Capsular tension ring implantation during phacoemulsification lens extraction and intraocular lens implantation combined with goniosynechialysis in included angle closure patients.
No capsular tension ring implantation during phacoemulsification lens extraction and intraocular lens implantation combined with goniosynechialysis in included angle closure patients.
Beijing Tongren Hospital
Beijing, China
Spherical equivalent
Sphere +1/2 cylinder obtained from subjective refraction
Time frame: baseline
Spherical equivalent
Sphere +1/2 cylinder obtained from subjective refraction
Time frame: 1 month after the surgery
Spherical equivalent
Sphere +1/2 cylinder obtained from subjective refraction
Time frame: 3 months after the surgery
Spherical equivalent
Sphere +1/2 cylinder obtained from subjective refraction
Time frame: 6 months after the surgery
Spherical equivalent
Sphere +1/2 cylinder obtained from subjective refraction
Time frame: 12 months after the surgery
Area of anterior capsulorhexis
Area of anterior capsulorhexis measured using slit-lamp photography
Time frame: 1 week after the surgery
Area of anterior capsulorhexis
Area of anterior capsulorhexis measured using slit-lamp photography
Time frame: 1 month after the surgery
Area of anterior capsulorhexis
Area of anterior capsulorhexis measured using slit-lamp photography
Time frame: 3 months after the surgery
Area of anterior capsulorhexis
Area of anterior capsulorhexis measured using slit-lamp photography
Time frame: 6 months after the surgery
Area of anterior capsulorhexis
Area of anterior capsulorhexis measured using slit-lamp photography
Time frame: 12 months after the surgery
Assessment of posterior capsular opacification
Assessment of posterior capsular opacification using slit-lamp photography
Time frame: 1 week after the surgery
Assessment of posterior capsular opacification
Assessment of posterior capsular opacification using slit-lamp photography
Time frame: 1 month after the surgery
Assessment of posterior capsular opacification
Assessment of posterior capsular opacification using slit-lamp photography
Time frame: 3 months after the surgery
Assessment of posterior capsular opacification
Assessment of posterior capsular opacification using slit-lamp photography
Time frame: 6 months after the surgery
Assessment of posterior capsular opacification
Assessment of posterior capsular opacification using slit-lamp photography
Time frame: 12 months after the surgery
The extent of iris-trabecular contact
The extent of iris-trabecular contact assessed by gonioscopy
Time frame: baseline
The extent of iris-trabecular contact
The extent of iris-trabecular contact assessed by gonioscopy
Time frame: 1 month after the surgery
The extent of iris-trabecular contact
The extent of iris-trabecular contact assessed by gonioscopy
Time frame: 3 months after the surgery
The extent of iris-trabecular contact
The extent of iris-trabecular contact assessed by gonioscopy
Time frame: 6 months after the surgery
The extent of iris-trabecular contact
The extent of iris-trabecular contact assessed by gonioscopy
Time frame: 12 months after the surgery
The extent of peripheral anterior synechia
The extent of peripheral anterior synechia assessed by gonioscopy
Time frame: baseline
The extent of peripheral anterior synechia
The extent of peripheral anterior synechia assessed by gonioscopy
Time frame: 1 month after the surgery
The extent of peripheral anterior synechia
The extent of peripheral anterior synechia assessed by gonioscopy
Time frame: 3 months after the surgery
The extent of peripheral anterior synechia
The extent of peripheral anterior synechia assessed by gonioscopy
Time frame: 6 months after the surgery
The extent of peripheral anterior synechia
The extent of peripheral anterior synechia assessed by gonioscopy
Time frame: 12 months after the surgery
Corneal thickness
Corneal thickness obtained by IOL Master 700
Time frame: baseline
Central anterior chamber depth
Central anterior chamber depth obtained by IOL Master 700
Time frame: baseline
Lens thickness
Lens thickness obtained by IOL Master 700
Time frame: baseline
Axial Length
Axial Length obtained by IOL Master 700
Time frame: baseline
Refractive prediction error
Refractive prediction error obtained by IOL Master 700
Time frame: baseline
Anterior chamber depth
Anterior chamber depth obtained by anterior segment optical coherence tomography
Time frame: baseline
Anterior chamber depth
Anterior chamber depth obtained by anterior segment optical coherence tomography
Time frame: 1 week after the surgery
Anterior chamber depth
Anterior chamber depth obtained by anterior segment optical coherence tomography
Time frame: 1 month after the surgery
Anterior chamber depth
Anterior chamber depth obtained by anterior segment optical coherence tomography
Time frame: 3 months after the surgery
Anterior chamber depth
Anterior chamber depth obtained by anterior segment optical coherence tomography
Time frame: 6 months after the surgery
Anterior chamber depth
Anterior chamber depth obtained by anterior segment optical coherence tomography
Time frame: 12 months after the surgery
Angle opening distance
Angle opening distance obtained by anterior segment optical coherence tomography
Time frame: baseline
Angle opening distance
Angle opening distance obtained by anterior segment optical coherence tomography
Time frame: 1 week after the surgery
Angle opening distance
Angle opening distance obtained by anterior segment optical coherence tomography
Time frame: 1 month after the surgery
Angle opening distance
Angle opening distance obtained by anterior segment optical coherence tomography
Time frame: 3 months after the surgery
Angle opening distance
Angle opening distance obtained by anterior segment optical coherence tomography
Time frame: 6 months after the surgery
Angle opening distance
Angle opening distance obtained by anterior segment optical coherence tomography
Time frame: 12 months after the surgery
Trabecular-iris space area
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Time frame: baseline
Trabecular-iris space area
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Time frame: 1 week after the surgery
Trabecular-iris space area
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Time frame: 1 month after the surgery
Trabecular-iris space area
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Time frame: 3 months after the surgery
Trabecular-iris space area
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Time frame: 6 months after the surgery
Trabecular-iris space area
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Time frame: 12 months after the surgery
Trabecular-iris angle
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Time frame: baseline
Trabecular-iris angle
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Time frame: 1 week after the surgery
Trabecular-iris angle
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Time frame: 1 month after the surgery
Trabecular-iris angle
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Time frame: 3 months after the surgery
Trabecular-iris angle
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Time frame: 6 months after the surgery
Trabecular-iris angle
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Time frame: 12 months after the surgery
Anterior chamber width
Anterior chamber width obtained by anterior segment optical coherence tomography
Time frame: baseline
Anterior chamber width
Anterior chamber width obtained by anterior segment optical coherence tomography
Time frame: 1 week after the surgery
Anterior chamber width
Anterior chamber width obtained by anterior segment optical coherence tomography
Time frame: 1 month after the surgery
Anterior chamber width
Anterior chamber width obtained by anterior segment optical coherence tomography
Time frame: 3 months after the surgery
Anterior chamber width
Anterior chamber width obtained by anterior segment optical coherence tomography
Time frame: 6 months after the surgery
Anterior chamber width
Anterior chamber width obtained by anterior segment optical coherence tomography
Time frame: 12 months after the surgery
Iris thickness
Iris thickness obtained by anterior segment optical coherence tomography
Time frame: baseline
Iris thickness
Iris thickness obtained by anterior segment optical coherence tomography
Time frame: 1 week after the surgery
Iris thickness
Iris thickness obtained by anterior segment optical coherence tomography
Time frame: 1 month after the surgery
Iris thickness
Iris thickness obtained by anterior segment optical coherence tomography
Time frame: 3 months after the surgery
Iris thickness
Iris thickness obtained by anterior segment optical coherence tomography
Time frame: 6 months after the surgery
Iris thickness
Iris thickness obtained by anterior segment optical coherence tomography
Time frame: 12 months after the surgery
Iris cross-sectional area
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Time frame: baseline
Iris cross-sectional area
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Time frame: 1 week after the surgery
Iris cross-sectional area
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Time frame: 1 month after the surgery
Iris cross-sectional area
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Time frame: 3 months after the surgery
Iris cross-sectional area
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Time frame: 6 months after the surgery
Iris cross-sectional area
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Time frame: 12 months after the surgery
Iris curvature
Iris curvature obtained by anterior segment optical coherence tomography
Time frame: baseline
Iris curvature
Iris curvature obtained by anterior segment optical coherence tomography
Time frame: 1 week after the surgery
Iris curvature
Iris curvature obtained by anterior segment optical coherence tomography
Time frame: 1 month after the surgery
Iris curvature
Iris curvature obtained by anterior segment optical coherence tomography
Time frame: 3 months after the surgery
Iris curvature
Iris curvature obtained by anterior segment optical coherence tomography
Time frame: 6 months after the surgery
Iris curvature
Iris curvature obtained by anterior segment optical coherence tomography
Time frame: 12 months after the surgery
Lens thickness
Lens thickness obtained by anterior segment optical coherence tomography
Time frame: baseline
Lens thickness
Lens thickness obtained by anterior segment optical coherence tomography
Time frame: 1 week after the surgery
Lens thickness
Lens thickness obtained by anterior segment optical coherence tomography
Time frame: 1 month after the surgery
Lens thickness
Lens thickness obtained by anterior segment optical coherence tomography
Time frame: 3 months after the surgery
Lens thickness
Lens thickness obtained by anterior segment optical coherence tomography
Time frame: 6 months after the surgery
Lens thickness
Lens thickness obtained by anterior segment optical coherence tomography
Time frame: 12 months after the surgery
Lens vault
Lens vault obtained by anterior segment optical coherence tomography
Time frame: baseline
Lens vault
Lens vault obtained by anterior segment optical coherence tomography
Time frame: 1 week after the surgery
Lens vault
Lens vault obtained by anterior segment optical coherence tomography
Time frame: 1 month after the surgery
Lens vault
Lens vault obtained by anterior segment optical coherence tomography
Time frame: 3 months after the surgery
Lens vault
Lens vault obtained by anterior segment optical coherence tomography
Time frame: 6 months after the surgery
Lens vault
Lens vault obtained by anterior segment optical coherence tomography
Time frame: 12 months after the surgery
The distance between intraocular lens and the posterior capsular
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
Time frame: 1 week after the surgery
The distance between intraocular lens and the posterior capsular
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
Time frame: 1 month after the surgery
The distance between intraocular lens and the posterior capsular
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
Time frame: 3 months after the surgery
The distance between intraocular lens and the posterior capsular
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
Time frame: 6 months after the surgery
The distance between intraocular lens and the posterior capsular
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
Time frame: 12 months after the surgery
Intraocular lens inclination angle
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Time frame: 1 week after the surgery
Intraocular lens inclination angle
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Time frame: 1 month after the surgery
Intraocular lens inclination angle
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Time frame: 3 months after the surgery
Intraocular lens inclination angle
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Time frame: 6 months after the surgery
Intraocular lens inclination angle
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Time frame: 12 months after the surgery
Effective intraocular lens position
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Time frame: 1 week after the surgery
Effective intraocular lens position
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Time frame: 1 month after the surgery
Effective intraocular lens position
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Time frame: 3 months after the surgery
Effective intraocular lens position
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Time frame: 6 months after the surgery
Effective intraocular lens position
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Time frame: 12 months after the surgery
The distance between ciliary body and the equator of lens at 3 o'clock position
The distance between ciliary body and the equator of lens at 3 o'clock position obtained by ultrasound biomicroscopy
Time frame: baseline
The distance between ciliary body and the equator of lens at 6 o'clock position
The distance between ciliary body and the equator of lens at 6 o'clock position obtained by ultrasound biomicroscopy
Time frame: baseline
The distance between ciliary body and the equator of lens at 9 o'clock position
The distance between ciliary body and the equator of lens at 9 o'clock position obtained by ultrasound biomicroscopy
Time frame: baseline
The distance between ciliary body and the equator of lens at 12 o'clock position
The distance between ciliary body and the equator of lens at 12 o'clock position obtained by ultrasound biomicroscopy
Time frame: baseline
Incidence of complications
Incidence of complications including posterior capsular opacification (PCO), IOL tilt, capsule contraction syndrome, et al.
Time frame: 1 month after the surgery
Incidence of complications
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
Time frame: 3 months after the surgery
Incidence of complications
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
Time frame: 6 months after the surgery
Incidence of complications
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
Time frame: 12 months after the surgery
Presenting visual acuity
Presenting visual acuity with or without glasses
Time frame: baseline
Presenting visual acuity
Presenting visual acuity with or without glasses
Time frame: 1 day after the surgery
Presenting visual acuity
Presenting visual acuity with or without glasses
Time frame: 1 week after the surgery
Presenting visual acuity
Presenting visual acuity with or without glasses
Time frame: 1 month after the surgery
Presenting visual acuity
Presenting visual acuity with or without glasses
Time frame: 3 months after the surgery
Presenting visual acuity
Presenting visual acuity with or without glasses
Time frame: 6 months after the surgery
Presenting visual acuity
Presenting visual acuity with or without glasses
Time frame: 12 months after the surgery
Best corrected visual acuity
Visual acuity with refractive correction
Time frame: baseline
Best corrected visual acuity
Visual acuity with refractive correction
Time frame: 1 month after the surgery
Best corrected visual acuity
Visual acuity with refractive correction
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Time frame: 3 months after the surgery
Best corrected visual acuity
Visual acuity with refractive correction
Time frame: 6 months after the surgery
Best corrected visual acuity
Visual acuity with refractive correction
Time frame: 12 months after the surgery
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Time frame: baseline
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Time frame: 1 day after the surgery
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Time frame: 1 week after the surgery
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Time frame: 1 month after the surgery
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Time frame: 3 months after the surgery
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Time frame: 6 months after the surgery
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Time frame: 12 months after the surgery
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Time frame: 1 week after the surgery
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Time frame: 1 month after the surgery
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Time frame: 3 months after the surgery
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Time frame: 6 months after the surgery
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Time frame: 12 months after the surgery
Vertical cup-to-disc ratio
Vertical cup-to-disc ratio evaluated by fundus photography
Time frame: baseline
Vertical cup-to-disc ratio
Vertical cup-to-disc ratio evaluated by fundus photography
Time frame: 1 month after the surgery
Vertical cup-to-disc ratio
Vertical cup-to-disc ratio evaluated by fundus photography
Time frame: 6 months after the surgery
Vertical cup-to-disc ratio
Vertical cup-to-disc ratio evaluated by fundus photography
Time frame: 12 months after the surgery