- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05542290
Implantation of Capsular Tension Ring in Primary Angle Closure Patients With Zonular Laxity or Dialysis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chunyan Qiao, M.D.
- Phone Number: 86-17610678637
- Email: chunyan_qiao@163.com
Study Locations
-
-
-
Beijing, China, 100730
- Beijing Tongren Hospital
-
Contact:
- Chunyan Qiao, M.D.
- Phone Number: 86017610678637
- Email: chunyan_qiao@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: With capsular tension ring implantation
We performed phacoemulsification lens extraction and intraocular lens implantation with capsular tension ring implantation combined with goniosynechialysis.
|
Capsular tension ring implantation during phacoemulsification lens extraction and intraocular lens implantation combined with goniosynechialysis in included angle closure patients.
|
Other: Without capsular tension ring implantation
We performed phacoemulsification lens extraction and intraocular lens implantation without capsular tension ring implantation combined with goniosynechialysis.
|
No capsular tension ring implantation during phacoemulsification lens extraction and intraocular lens implantation combined with goniosynechialysis in included angle closure patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spherical equivalent
Time Frame: baseline
|
Sphere +1/2 cylinder obtained from subjective refraction
|
baseline
|
Spherical equivalent
Time Frame: 1 month after the surgery
|
Sphere +1/2 cylinder obtained from subjective refraction
|
1 month after the surgery
|
Spherical equivalent
Time Frame: 3 months after the surgery
|
Sphere +1/2 cylinder obtained from subjective refraction
|
3 months after the surgery
|
Spherical equivalent
Time Frame: 6 months after the surgery
|
Sphere +1/2 cylinder obtained from subjective refraction
|
6 months after the surgery
|
Spherical equivalent
Time Frame: 12 months after the surgery
|
Sphere +1/2 cylinder obtained from subjective refraction
|
12 months after the surgery
|
Area of anterior capsulorhexis
Time Frame: 1 week after the surgery
|
Area of anterior capsulorhexis measured using slit-lamp photography
|
1 week after the surgery
|
Area of anterior capsulorhexis
Time Frame: 1 month after the surgery
|
Area of anterior capsulorhexis measured using slit-lamp photography
|
1 month after the surgery
|
Area of anterior capsulorhexis
Time Frame: 3 months after the surgery
|
Area of anterior capsulorhexis measured using slit-lamp photography
|
3 months after the surgery
|
Area of anterior capsulorhexis
Time Frame: 6 months after the surgery
|
Area of anterior capsulorhexis measured using slit-lamp photography
|
6 months after the surgery
|
Area of anterior capsulorhexis
Time Frame: 12 months after the surgery
|
Area of anterior capsulorhexis measured using slit-lamp photography
|
12 months after the surgery
|
Assessment of posterior capsular opacification
Time Frame: 1 week after the surgery
|
Assessment of posterior capsular opacification using slit-lamp photography
|
1 week after the surgery
|
Assessment of posterior capsular opacification
Time Frame: 1 month after the surgery
|
Assessment of posterior capsular opacification using slit-lamp photography
|
1 month after the surgery
|
Assessment of posterior capsular opacification
Time Frame: 3 months after the surgery
|
Assessment of posterior capsular opacification using slit-lamp photography
|
3 months after the surgery
|
Assessment of posterior capsular opacification
Time Frame: 6 months after the surgery
|
Assessment of posterior capsular opacification using slit-lamp photography
|
6 months after the surgery
|
Assessment of posterior capsular opacification
Time Frame: 12 months after the surgery
|
Assessment of posterior capsular opacification using slit-lamp photography
|
12 months after the surgery
|
The extent of iris-trabecular contact
Time Frame: baseline
|
The extent of iris-trabecular contact assessed by gonioscopy
|
baseline
|
The extent of iris-trabecular contact
Time Frame: 1 month after the surgery
|
The extent of iris-trabecular contact assessed by gonioscopy
|
1 month after the surgery
|
The extent of iris-trabecular contact
Time Frame: 3 months after the surgery
|
The extent of iris-trabecular contact assessed by gonioscopy
|
3 months after the surgery
|
The extent of iris-trabecular contact
Time Frame: 6 months after the surgery
|
The extent of iris-trabecular contact assessed by gonioscopy
|
6 months after the surgery
|
The extent of iris-trabecular contact
Time Frame: 12 months after the surgery
|
The extent of iris-trabecular contact assessed by gonioscopy
|
12 months after the surgery
|
The extent of peripheral anterior synechia
Time Frame: baseline
|
The extent of peripheral anterior synechia assessed by gonioscopy
|
baseline
|
The extent of peripheral anterior synechia
Time Frame: 1 month after the surgery
|
The extent of peripheral anterior synechia assessed by gonioscopy
|
1 month after the surgery
|
The extent of peripheral anterior synechia
Time Frame: 3 months after the surgery
|
The extent of peripheral anterior synechia assessed by gonioscopy
|
3 months after the surgery
|
The extent of peripheral anterior synechia
Time Frame: 6 months after the surgery
|
The extent of peripheral anterior synechia assessed by gonioscopy
|
6 months after the surgery
|
The extent of peripheral anterior synechia
Time Frame: 12 months after the surgery
|
The extent of peripheral anterior synechia assessed by gonioscopy
|
12 months after the surgery
|
Corneal thickness
Time Frame: baseline
|
Corneal thickness obtained by IOL Master 700
|
baseline
|
Central anterior chamber depth
Time Frame: baseline
|
Central anterior chamber depth obtained by IOL Master 700
|
baseline
|
Lens thickness
Time Frame: baseline
|
Lens thickness obtained by IOL Master 700
|
baseline
|
Axial Length
Time Frame: baseline
|
Axial Length obtained by IOL Master 700
|
baseline
|
Refractive prediction error
Time Frame: baseline
|
Refractive prediction error obtained by IOL Master 700
|
baseline
|
Anterior chamber depth
Time Frame: baseline
|
Anterior chamber depth obtained by anterior segment optical coherence tomography
|
baseline
|
Anterior chamber depth
Time Frame: 1 week after the surgery
|
Anterior chamber depth obtained by anterior segment optical coherence tomography
|
1 week after the surgery
|
Anterior chamber depth
Time Frame: 1 month after the surgery
|
Anterior chamber depth obtained by anterior segment optical coherence tomography
|
1 month after the surgery
|
Anterior chamber depth
Time Frame: 3 months after the surgery
|
Anterior chamber depth obtained by anterior segment optical coherence tomography
|
3 months after the surgery
|
Anterior chamber depth
Time Frame: 6 months after the surgery
|
Anterior chamber depth obtained by anterior segment optical coherence tomography
|
6 months after the surgery
|
Anterior chamber depth
Time Frame: 12 months after the surgery
|
Anterior chamber depth obtained by anterior segment optical coherence tomography
|
12 months after the surgery
|
Angle opening distance
Time Frame: baseline
|
Angle opening distance obtained by anterior segment optical coherence tomography
|
baseline
|
Angle opening distance
Time Frame: 1 week after the surgery
|
Angle opening distance obtained by anterior segment optical coherence tomography
|
1 week after the surgery
|
Angle opening distance
Time Frame: 1 month after the surgery
|
Angle opening distance obtained by anterior segment optical coherence tomography
|
1 month after the surgery
|
Angle opening distance
Time Frame: 3 months after the surgery
|
Angle opening distance obtained by anterior segment optical coherence tomography
|
3 months after the surgery
|
Angle opening distance
Time Frame: 6 months after the surgery
|
Angle opening distance obtained by anterior segment optical coherence tomography
|
6 months after the surgery
|
Angle opening distance
Time Frame: 12 months after the surgery
|
Angle opening distance obtained by anterior segment optical coherence tomography
|
12 months after the surgery
|
Trabecular-iris space area
Time Frame: baseline
|
Trabecular-iris space area obtained by anterior segment optical coherence tomography
|
baseline
|
Trabecular-iris space area
Time Frame: 1 week after the surgery
|
Trabecular-iris space area obtained by anterior segment optical coherence tomography
|
1 week after the surgery
|
Trabecular-iris space area
Time Frame: 1 month after the surgery
|
Trabecular-iris space area obtained by anterior segment optical coherence tomography
|
1 month after the surgery
|
Trabecular-iris space area
Time Frame: 3 months after the surgery
|
Trabecular-iris space area obtained by anterior segment optical coherence tomography
|
3 months after the surgery
|
Trabecular-iris space area
Time Frame: 6 months after the surgery
|
Trabecular-iris space area obtained by anterior segment optical coherence tomography
|
6 months after the surgery
|
Trabecular-iris space area
Time Frame: 12 months after the surgery
|
Trabecular-iris space area obtained by anterior segment optical coherence tomography
|
12 months after the surgery
|
Trabecular-iris angle
Time Frame: baseline
|
Trabecular-iris angle obtained by anterior segment optical coherence tomography
|
baseline
|
Trabecular-iris angle
Time Frame: 1 week after the surgery
|
Trabecular-iris angle obtained by anterior segment optical coherence tomography
|
1 week after the surgery
|
Trabecular-iris angle
Time Frame: 1 month after the surgery
|
Trabecular-iris angle obtained by anterior segment optical coherence tomography
|
1 month after the surgery
|
Trabecular-iris angle
Time Frame: 3 months after the surgery
|
Trabecular-iris angle obtained by anterior segment optical coherence tomography
|
3 months after the surgery
|
Trabecular-iris angle
Time Frame: 6 months after the surgery
|
Trabecular-iris angle obtained by anterior segment optical coherence tomography
|
6 months after the surgery
|
Trabecular-iris angle
Time Frame: 12 months after the surgery
|
Trabecular-iris angle obtained by anterior segment optical coherence tomography
|
12 months after the surgery
|
Anterior chamber width
Time Frame: baseline
|
Anterior chamber width obtained by anterior segment optical coherence tomography
|
baseline
|
Anterior chamber width
Time Frame: 1 week after the surgery
|
Anterior chamber width obtained by anterior segment optical coherence tomography
|
1 week after the surgery
|
Anterior chamber width
Time Frame: 1 month after the surgery
|
Anterior chamber width obtained by anterior segment optical coherence tomography
|
1 month after the surgery
|
Anterior chamber width
Time Frame: 3 months after the surgery
|
Anterior chamber width obtained by anterior segment optical coherence tomography
|
3 months after the surgery
|
Anterior chamber width
Time Frame: 6 months after the surgery
|
Anterior chamber width obtained by anterior segment optical coherence tomography
|
6 months after the surgery
|
Anterior chamber width
Time Frame: 12 months after the surgery
|
Anterior chamber width obtained by anterior segment optical coherence tomography
|
12 months after the surgery
|
Iris thickness
Time Frame: baseline
|
Iris thickness obtained by anterior segment optical coherence tomography
|
baseline
|
Iris thickness
Time Frame: 1 week after the surgery
|
Iris thickness obtained by anterior segment optical coherence tomography
|
1 week after the surgery
|
Iris thickness
Time Frame: 1 month after the surgery
|
Iris thickness obtained by anterior segment optical coherence tomography
|
1 month after the surgery
|
Iris thickness
Time Frame: 3 months after the surgery
|
Iris thickness obtained by anterior segment optical coherence tomography
|
3 months after the surgery
|
Iris thickness
Time Frame: 6 months after the surgery
|
Iris thickness obtained by anterior segment optical coherence tomography
|
6 months after the surgery
|
Iris thickness
Time Frame: 12 months after the surgery
|
Iris thickness obtained by anterior segment optical coherence tomography
|
12 months after the surgery
|
Iris cross-sectional area
Time Frame: baseline
|
Iris cross-sectional area obtained by anterior segment optical coherence tomography
|
baseline
|
Iris cross-sectional area
Time Frame: 1 week after the surgery
|
Iris cross-sectional area obtained by anterior segment optical coherence tomography
|
1 week after the surgery
|
Iris cross-sectional area
Time Frame: 1 month after the surgery
|
Iris cross-sectional area obtained by anterior segment optical coherence tomography
|
1 month after the surgery
|
Iris cross-sectional area
Time Frame: 3 months after the surgery
|
Iris cross-sectional area obtained by anterior segment optical coherence tomography
|
3 months after the surgery
|
Iris cross-sectional area
Time Frame: 6 months after the surgery
|
Iris cross-sectional area obtained by anterior segment optical coherence tomography
|
6 months after the surgery
|
Iris cross-sectional area
Time Frame: 12 months after the surgery
|
Iris cross-sectional area obtained by anterior segment optical coherence tomography
|
12 months after the surgery
|
Iris curvature
Time Frame: baseline
|
Iris curvature obtained by anterior segment optical coherence tomography
|
baseline
|
Iris curvature
Time Frame: 1 week after the surgery
|
Iris curvature obtained by anterior segment optical coherence tomography
|
1 week after the surgery
|
Iris curvature
Time Frame: 1 month after the surgery
|
Iris curvature obtained by anterior segment optical coherence tomography
|
1 month after the surgery
|
Iris curvature
Time Frame: 3 months after the surgery
|
Iris curvature obtained by anterior segment optical coherence tomography
|
3 months after the surgery
|
Iris curvature
Time Frame: 6 months after the surgery
|
Iris curvature obtained by anterior segment optical coherence tomography
|
6 months after the surgery
|
Iris curvature
Time Frame: 12 months after the surgery
|
Iris curvature obtained by anterior segment optical coherence tomography
|
12 months after the surgery
|
Lens thickness
Time Frame: baseline
|
Lens thickness obtained by anterior segment optical coherence tomography
|
baseline
|
Lens thickness
Time Frame: 1 week after the surgery
|
Lens thickness obtained by anterior segment optical coherence tomography
|
1 week after the surgery
|
Lens thickness
Time Frame: 1 month after the surgery
|
Lens thickness obtained by anterior segment optical coherence tomography
|
1 month after the surgery
|
Lens thickness
Time Frame: 3 months after the surgery
|
Lens thickness obtained by anterior segment optical coherence tomography
|
3 months after the surgery
|
Lens thickness
Time Frame: 6 months after the surgery
|
Lens thickness obtained by anterior segment optical coherence tomography
|
6 months after the surgery
|
Lens thickness
Time Frame: 12 months after the surgery
|
Lens thickness obtained by anterior segment optical coherence tomography
|
12 months after the surgery
|
Lens vault
Time Frame: baseline
|
Lens vault obtained by anterior segment optical coherence tomography
|
baseline
|
Lens vault
Time Frame: 1 week after the surgery
|
Lens vault obtained by anterior segment optical coherence tomography
|
1 week after the surgery
|
Lens vault
Time Frame: 1 month after the surgery
|
Lens vault obtained by anterior segment optical coherence tomography
|
1 month after the surgery
|
Lens vault
Time Frame: 3 months after the surgery
|
Lens vault obtained by anterior segment optical coherence tomography
|
3 months after the surgery
|
Lens vault
Time Frame: 6 months after the surgery
|
Lens vault obtained by anterior segment optical coherence tomography
|
6 months after the surgery
|
Lens vault
Time Frame: 12 months after the surgery
|
Lens vault obtained by anterior segment optical coherence tomography
|
12 months after the surgery
|
The distance between intraocular lens and the posterior capsular
Time Frame: 1 week after the surgery
|
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
|
1 week after the surgery
|
The distance between intraocular lens and the posterior capsular
Time Frame: 1 month after the surgery
|
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
|
1 month after the surgery
|
The distance between intraocular lens and the posterior capsular
Time Frame: 3 months after the surgery
|
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
|
3 months after the surgery
|
The distance between intraocular lens and the posterior capsular
Time Frame: 6 months after the surgery
|
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
|
6 months after the surgery
|
The distance between intraocular lens and the posterior capsular
Time Frame: 12 months after the surgery
|
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
|
12 months after the surgery
|
Intraocular lens inclination angle
Time Frame: 1 week after the surgery
|
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
|
1 week after the surgery
|
Intraocular lens inclination angle
Time Frame: 1 month after the surgery
|
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
|
1 month after the surgery
|
Intraocular lens inclination angle
Time Frame: 3 months after the surgery
|
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
|
3 months after the surgery
|
Intraocular lens inclination angle
Time Frame: 6 months after the surgery
|
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
|
6 months after the surgery
|
Intraocular lens inclination angle
Time Frame: 12 months after the surgery
|
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
|
12 months after the surgery
|
Effective intraocular lens position
Time Frame: 1 week after the surgery
|
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
|
1 week after the surgery
|
Effective intraocular lens position
Time Frame: 1 month after the surgery
|
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
|
1 month after the surgery
|
Effective intraocular lens position
Time Frame: 3 months after the surgery
|
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
|
3 months after the surgery
|
Effective intraocular lens position
Time Frame: 6 months after the surgery
|
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
|
6 months after the surgery
|
Effective intraocular lens position
Time Frame: 12 months after the surgery
|
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
|
12 months after the surgery
|
The distance between ciliary body and the equator of lens at 3 o'clock position
Time Frame: baseline
|
The distance between ciliary body and the equator of lens at 3 o'clock position obtained by ultrasound biomicroscopy
|
baseline
|
The distance between ciliary body and the equator of lens at 6 o'clock position
Time Frame: baseline
|
The distance between ciliary body and the equator of lens at 6 o'clock position obtained by ultrasound biomicroscopy
|
baseline
|
The distance between ciliary body and the equator of lens at 9 o'clock position
Time Frame: baseline
|
The distance between ciliary body and the equator of lens at 9 o'clock position obtained by ultrasound biomicroscopy
|
baseline
|
The distance between ciliary body and the equator of lens at 12 o'clock position
Time Frame: baseline
|
The distance between ciliary body and the equator of lens at 12 o'clock position obtained by ultrasound biomicroscopy
|
baseline
|
Incidence of complications
Time Frame: 1 month after the surgery
|
Incidence of complications including posterior capsular opacification (PCO), IOL tilt, capsule contraction syndrome, et al.
|
1 month after the surgery
|
Incidence of complications
Time Frame: 3 months after the surgery
|
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
|
3 months after the surgery
|
Incidence of complications
Time Frame: 6 months after the surgery
|
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
|
6 months after the surgery
|
Incidence of complications
Time Frame: 12 months after the surgery
|
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
|
12 months after the surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presenting visual acuity
Time Frame: baseline
|
Presenting visual acuity with or without glasses
|
baseline
|
Presenting visual acuity
Time Frame: 1 day after the surgery
|
Presenting visual acuity with or without glasses
|
1 day after the surgery
|
Presenting visual acuity
Time Frame: 1 week after the surgery
|
Presenting visual acuity with or without glasses
|
1 week after the surgery
|
Presenting visual acuity
Time Frame: 1 month after the surgery
|
Presenting visual acuity with or without glasses
|
1 month after the surgery
|
Presenting visual acuity
Time Frame: 3 months after the surgery
|
Presenting visual acuity with or without glasses
|
3 months after the surgery
|
Presenting visual acuity
Time Frame: 6 months after the surgery
|
Presenting visual acuity with or without glasses
|
6 months after the surgery
|
Presenting visual acuity
Time Frame: 12 months after the surgery
|
Presenting visual acuity with or without glasses
|
12 months after the surgery
|
Best corrected visual acuity
Time Frame: baseline
|
Visual acuity with refractive correction
|
baseline
|
Best corrected visual acuity
Time Frame: 1 month after the surgery
|
Visual acuity with refractive correction
|
1 month after the surgery
|
Best corrected visual acuity
Time Frame: 3 months after the surgery
|
Visual acuity with refractive correction
|
3 months after the surgery
|
Best corrected visual acuity
Time Frame: 6 months after the surgery
|
Visual acuity with refractive correction
|
6 months after the surgery
|
Best corrected visual acuity
Time Frame: 12 months after the surgery
|
Visual acuity with refractive correction
|
12 months after the surgery
|
Intraocular pressure
Time Frame: baseline
|
Intraocular pressure obtained by non-contact tonometer
|
baseline
|
Intraocular pressure
Time Frame: 1 day after the surgery
|
Intraocular pressure obtained by non-contact tonometer
|
1 day after the surgery
|
Intraocular pressure
Time Frame: 1 week after the surgery
|
Intraocular pressure obtained by non-contact tonometer
|
1 week after the surgery
|
Intraocular pressure
Time Frame: 1 month after the surgery
|
Intraocular pressure obtained by non-contact tonometer
|
1 month after the surgery
|
Intraocular pressure
Time Frame: 3 months after the surgery
|
Intraocular pressure obtained by non-contact tonometer
|
3 months after the surgery
|
Intraocular pressure
Time Frame: 6 months after the surgery
|
Intraocular pressure obtained by non-contact tonometer
|
6 months after the surgery
|
Intraocular pressure
Time Frame: 12 months after the surgery
|
Intraocular pressure obtained by non-contact tonometer
|
12 months after the surgery
|
Number of anti-glaucoma medications
Time Frame: 1 week after the surgery
|
Number of anti-glaucoma medications
|
1 week after the surgery
|
Number of anti-glaucoma medications
Time Frame: 1 month after the surgery
|
Number of anti-glaucoma medications
|
1 month after the surgery
|
Number of anti-glaucoma medications
Time Frame: 3 months after the surgery
|
Number of anti-glaucoma medications
|
3 months after the surgery
|
Number of anti-glaucoma medications
Time Frame: 6 months after the surgery
|
Number of anti-glaucoma medications
|
6 months after the surgery
|
Number of anti-glaucoma medications
Time Frame: 12 months after the surgery
|
Number of anti-glaucoma medications
|
12 months after the surgery
|
Vertical cup-to-disc ratio
Time Frame: baseline
|
Vertical cup-to-disc ratio evaluated by fundus photography
|
baseline
|
Vertical cup-to-disc ratio
Time Frame: 1 month after the surgery
|
Vertical cup-to-disc ratio evaluated by fundus photography
|
1 month after the surgery
|
Vertical cup-to-disc ratio
Time Frame: 6 months after the surgery
|
Vertical cup-to-disc ratio evaluated by fundus photography
|
6 months after the surgery
|
Vertical cup-to-disc ratio
Time Frame: 12 months after the surgery
|
Vertical cup-to-disc ratio evaluated by fundus photography
|
12 months after the surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BeijingTH-CTR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Sanoculis LtdCompletedPrimary Open Angle Glaucoma | Pigmentary Glaucoma | Pseudoexfoliative GlaucomaIsrael
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Sensimed AGCompletedPrimary Open Angle Glaucoma | Pigmentary Glaucoma | Pseudoexfoliative GlaucomaFrance
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Clinical Trials on Capsular tension ring implantation
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AurolabUnknown
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Yonsei UniversityCompleted
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Medical University of ViennaCompleted
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