Glaucoma, Closed-AngleNCT03686072
Cataract Surgery Combined With Endoscopic Goniosynechialysis for Advanced Primary Angle Closure Glaucoma
A study testing Cataract surgery with endoscopic goniosynechialysis in people with Glaucoma, Closed-Angle, run by Wenzhou Medical University.
Trial summary
In this prospective study, consecutive patients with advanced PACG and cataract who underwent Phaco-IOL-EGSL were invited to participate. Inclusion and exclusion criteria Inclusion criteria included: a diagnosis of PACG according to the International Society of Geographical \& Epidemiological Ophthalmology (ISGEO)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma, Closed-Angle
- What is being tested?
- Cataract surgery with endoscopic goniosynechialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- a diagnosis of PACG according to the International Society of Geographical \& Epidemiological Ophthalmology (ISGEO) diagnostic criteria,[14] visual field score ≥18 calculated (as per the method used in the Advanced Glaucoma Intervention Study [AGIS]),[15] treatment with IOP-lowering drugs for more than 3 months, and mild to moderate cataract.
Who cannot join
- secondary angle-closure glaucoma and previous history of surgery, except laser peripheral iridotomy.
About this study
Official title: Head of Glaucoma, Clinical Professor
In this prospective study, consecutive patients with advanced PACG and cataract who underwent Phaco-IOL-EGSL were invited to participate.
Inclusion and exclusion criteria Inclusion criteria included: a diagnosis of PACG according to the International Society of Geographical \& Epidemiological Ophthalmology (ISGEO) diagnostic criteria,14 visual field score ≥18 calculated (as per the method used in the Advanced Glaucoma Intervention Study [AGIS]),15 treatment with IOP-lowering drugs for more than 3 months, and mild to moderate cataract. Exclusion criteria included: secondary angle-closure glaucoma and previous history of surgery, except laser peripheral iridotomy.
Read more
Preoperative and postoperative examinations Preoperative examinations included: best corrected logMAR visual acuity (BCVA), number of intraocular pressure (IOP) lowering drugs, slit lamp and fundus examination, gonioscopy, Goldmann applanation tonometry and ultrasound biomicroscopy (UBM). Visual field tests were conducted with a Humphrey Visual Field Analyzer II.
All patients were reviewed at 1 week, 1 month, 3 months, 6 months and 12 months after surgery. The number of IOP-lowering drugs and IOP was observed and recorded at each follow-up. The extent of peripheral anterior synechiae , the BCVA and the visual field were recorded at 12 months following surgery.
Surgery procedure All patients used IOP-lowering drugs before surgery; IOP was controlled under 21mmHg where possible. If the preoperative IOP was over 40mmHg a preoperative anterior chamber paracentesis was performed. All surgeries were performed by the same experienced surgeon (WP). Intraoperative and postoperative complications were recorded.
In all patients, phacoemulsification was performed first. After implantation of the IOL, an ophthalmic endoscope (OE) probe was inserted into the anterior chamber to visualize the PAS through the main incision and side incision. A viscoelastic agent was injected towards the root of the iris where PAS existed. Then a blunt iris spatula was used to release the areas where PAS remained under direct view with the OE. Complete synechialysis was confirmed under the direct view with the OE at the end of the procedure.
Success criteria Based on the AGIS study, we defined surgical success as follows: (1) Standard A: IOP<14mmHg using none or one type of IOP-lowering drug; (2) Standard B: IOP <18mmHg using none or one type of IOP-lowering drug.
Read the detailed description
Introduction The prevalence of primary angle-closure glaucoma (PACG) is approximately 0.1% of the general population over 40 years of age but up to 1.5% of the Chinese population over 50 years of age. Studies predict that the number of cases of PACG in Asia will increase by 2040.4 Because PACG appears to cause blindness more frequently than primary open-angle glaucoma (POAG), it is considered to be the main cause of binocular glaucoma blindness and reduced quality of life in China. Early diagnosis of PACG is difficult; advanced cases at presentation are not uncommon.
In recent years cataract surgery (phacoemulsification with intraocular lens implantation) combined with goniosynechialysis (Phaco-IOL-GSL) has become more widely used in the treatment of PACG.8-11 Compared with the classic glaucoma filtration surgery, Phaco-IOL-GSL does not involve the creation of a filtering bleb with the need for long-term close follow-up. This is important for patients with poor compliance or difficulty with travel. However, the efficacy and risk of Phaco-IOL-GSL in patients with advanced glaucoma has not been reported. We prospectively performed phacoemulsification combined with intraocular lens implantation combined with endoscopic goniosynechialysis (Phaco-IOL-EGSL) in patients with advanced angle-closure glaucoma, and explored the efficacy and risk of the surgery.
Materials and methods Subjects Our objective was to measure the extent of PAS, number of intraocular pressure(IOP) lowering drugs, IOP, BCVA and visual field before and after surgery in patients with advanced PACG, to investigate the efficacy and safety of Phaco-IOL-EGSL. We also evaluate the correlation between the two groups of data.
In this prospective study, consecutive patients with advanced PACG and cataract who underwent Phaco-IOL-EGSL were invited to participate. The study was approved by the Ethics Committee of the Affiliated Eye Hospital of Wenzhou Medical University and informed consent was obtained from all patients, adhered to the tenets of the Declaration of Helsinki. All patients were treated at the Affiliated Eye Hospital of Wenzhou Medical University between February 2014 and March 2016. A total of 17 subjects (19 eyes) were enrolled in the study. Patients were followed up for 12 months. One patient was lost during follow-up, and 16 subjects (18 eyes) were analyzed in this study. No patient refused to participate in the study.
Inclusion and exclusion criteria Inclusion criteria included: a diagnosis of PACG according to the International Society of Geographical \& Epidemiological Ophthalmology (ISGEO) diagnostic criteria,14 visual field score ≥18 calculated (as per the method used in the Advanced Glaucoma Intervention Study [AGIS]), treatment with IOP-lowering drugs for more than 3 months, and mild to moderate cataract. Exclusion criteria included: secondary angle-closure glaucoma and previous history of surgery, except laser peripheral iridotomy.
Preoperative and postoperative examinations Preoperative examinations included: best corrected logMAR visual acuity (BCVA), number of intraocular pressure (IOP) lowering drugs, slit lamp and fundus examination, gonioscopy, Goldmann applanation tonometry and ultrasound biomicroscopy (UBM) (Suowei, Tianjin, China). Visual field tests were conducted with a Humphrey Visual Field Analyzer II (central 30-2 threshold test, size III white stimulus, and SITA-FAST strategy, with the foveal threshold test turned on).
Gonioscopy was performed in a dark room by the same experienced glaucoma specialist (WP) using a Zeiss-style 4-mirror lens (Zeiss Corp, Germany). The examination start with the inferior angle by looking through the superior mirror, the corneal wedge is used to orient oneself to the anatomy.16 The extent of PAS was evaluated by performing indentation gonioscopy around the entire circumference of angle.
All patients were reviewed at 1 week, 1 month, 3 months, 6 months and 12 months after surgery. The number of IOP-lowering drugs and IOP was observed and recorded at each follow-up. The extent of peripheral anterior synechiae , the BCVA and the visual field were recorded at 12 months following surgery.
Surgery procedure All patients used IOP-lowering drugs before surgery; IOP was controlled under 21mmHg where possible. If the preoperative IOP was over 40mmHg a preoperative anterior chamber paracentesis was performed. All surgeries were performed by the same experienced surgeon (WP). Intraoperative and postoperative complications were recorded.
Anaesthesia consisted of topical 0.5% proparacaine and a peribulbar block with bupivacaine. Then conventional phacoemulsification and IOL implantation (CT ASPHINA 509M, Zeiss Corp.) were performed. In all patients, phacoemulsification was performed using the following fluidic parameters: bottle height between 70 and 90 cm, a fixed aspiration flow rate (AFR) of 20 cc/min, and vacuum settings up to 350 mmHg, depending on the grade of nuclear sclerosis. Immediately after implantation of the IOL, a 23G ophthalmic endoscope (OE) probe (URAM E2, USA ENDO OPTIKS) was inserted into the anterior chamber to visualize the PAS through the main incision and side incision. A viscoelastic agent was injected towards the root of the iris where PAS existed (Figure 1A). Then a blunt iris spatula was used to release the areas where PAS remained. The tip was gently moved anteroposterior near the root of the iris in either a clockwise or a counterclockwise direction to release PAS under direct view with the OE (Figure 1B). Both the main incision and a second incision were used to ensure all PAS areas were released. Complete synechialysis was confirmed under the direct view with the OE at the end of the procedure. Using an irrigation and aspiration handpiece from the phaco machine, balanced salt solution replaced the viscoelastic agent. The incision was closed by hydration or sutured with 10-0 nylon if necessary.
Patients used Pranoprofen eye drops (Senju Pharmaceutical Co., Ltd., Japan) and Levofloxacin eye drops (Santen, Japan) four times a day and 0.5% pilocarpine eyedrops (Bausch \& Lomb, America) two times a day for four weeks after the surgery. Patients also used 1% prednisolone acetate eye drops (Allergan Pharmaceuticals, Ireland) four times a day for the first week after the surgery, and then reduced by one drop per week for a total of four weeks.
Success criteria Based on the AGIS study, we defined surgical success as follows: (1) Standard A: IOP<14mmHg using none or one type of IOP-lowering drug; (2) Standard B: IOP <18mmHg using none or one type of IOP-lowering drug.17 Statistical analysis All statistical analyses were performed using SPSS 20.0 statistical software. All data were represented by mean ± standard deviation (SD). The paired t-test was used to evaluate the differences in the extent of PAS, number of IOP lowering drugs, mean deviation , IOP and BCVA. A Spearman rank correlation coefficient was calculated to evaluate the correlation between the two groups of data.18 Statistical significance was set with a P-value <0.05.
- Conditions
- Glaucoma, Closed-Angle
- Being tested
- Cataract surgery with endoscopic goniosynechialysis
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgery with endoscopic goniosynechialysisProcedure or surgery
Phacoemulsification was performed first. Immediately after implantation of the IOL, a 23G ophthalmic endoscope (OE) probe was inserted into the anterior chamber to visualize the PAS through the main incision and side incision. A viscoelastic agent and a blunt iris spatula were used to release the areas where where PAS existed.
| Study group | Role | What they receive |
|---|---|---|
| Cataract surgery with goniosynechialysis | Other | Not described Receives: Procedure: Cataract surgery with endoscopic goniosynechialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The extent of peripheral anterior synechiae (PAS)
observed the the extent of PAS before and after surgery
Measured: Change from Baseline PAS at 12 months
number of intraocular pressure (IOP) lowering drugs
observed the the number of IOP lowering drugs before and after surgery
Measured: Change from Baseline IOP lowering drugs at 12 months
IOP
IOP before and after surgery
Measured: Change from Baseline IOP at 12 months
best corrected visual acuity
best corrected visual acuity before and after surgery
Measured: Change from Baseline best corrected visual acuity at 12 months
visual field
Mean defect(MD)of visual field before and after surgery
Measured: Change from Baseline MD of visual field at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study startFeb 2014
- Primary completionSep 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Closed-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yin ying zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686072
- Sponsor's protocol ID
- QZB-HZ-PHACO-EGSL
- Status last verified
- Sep 2018
- First submitted
- 21 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head of Glaucoma, Clinical Professor
- ClinicalTrials.gov ID
- NCT03686072
- Acronym / sponsor ID
- QZB-HZ-PHACO-EGSL
- Conditions
- Glaucoma, Closed-Angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this prospective study, consecutive patients with advanced PACG and cataract who underwent Phaco-IOL-EGSL were invited to participate.
Inclusion and exclusion criteria Inclusion criteria included: a diagnosis of PACG according to the International Society of Geographical \& Epidemiological Ophthalmology (ISGEO) diagnostic criteria,14 visual field score ≥18 calculated (as per the method used in the Advanced Glaucoma Intervention Study [AGIS]),15 treatment with IOP-lowering drugs for more than 3 months, and mild to moderate cataract. Exclusion criteria included: secondary angle-closure glaucoma and previous history of surgery, except laser peripheral iridotomy.
Preoperative and postoperative examinations Preoperative examinations included: best corrected logMAR visual acuity (BCVA), number of intraocular pressure (IOP) lowering drugs, slit lamp and fundus examination, gonioscopy, Goldmann applanation tonometry and ultrasound biomicroscopy (UBM). Visual field tests were conducted with a Humphrey Visual Field Analyzer II.
All patients were reviewed at 1 week, 1 month, 3 months, 6 months and 12 months after surgery. The number of IOP-lowering drugs and IOP was observed and recorded at each follow-up. The extent of peripheral anterior synechiae , the BCVA and the visual field were recorded at 12 months following surgery.
Surgery procedure All patients used IOP-lowering drugs before surgery; IOP was controlled under 21mmHg where possible. If the preoperative IOP was over 40mmHg a preoperative anterior chamber paracentesis was performed. All surgeries were performed by the same experienced surgeon (WP). Intraoperative and postoperative complications were recorded.
In all patients, phacoemulsification was performed first. After implantation of the IOL, an ophthalmic endoscope (OE) probe was inserted into the anterior chamber to visualize the PAS through the main incision and side incision. A viscoelastic agent was injected towards the root of the iris where PAS existed. Then a blunt iris spatula was used to release the areas where PAS remained under direct view with the OE. Complete synechialysis was confirmed under the direct view with the OE at the end of the procedure.
Success criteria Based on the AGIS study, we defined surgical success as follows: (1) Standard A: IOP<14mmHg using none or one type of IOP-lowering drug; (2) Standard B: IOP <18mmHg using none or one type of IOP-lowering drug.
Detailed description
Introduction The prevalence of primary angle-closure glaucoma (PACG) is approximately 0.1% of the general population over 40 years of age but up to 1.5% of the Chinese population over 50 years of age. Studies predict that the number of cases of PACG in Asia will increase by 2040.4 Because PACG appears to cause blindness more frequently than primary open-angle glaucoma (POAG), it is considered to be the main cause of binocular glaucoma blindness and reduced quality of life in China. Early diagnosis of PACG is difficult; advanced cases at presentation are not uncommon.
In recent years cataract surgery (phacoemulsification with intraocular lens implantation) combined with goniosynechialysis (Phaco-IOL-GSL) has become more widely used in the treatment of PACG.8-11 Compared with the classic glaucoma filtration surgery, Phaco-IOL-GSL does not involve the creation of a filtering bleb with the need for long-term close follow-up. This is important for patients with poor compliance or difficulty with travel. However, the efficacy and risk of Phaco-IOL-GSL in patients with advanced glaucoma has not been reported. We prospectively performed phacoemulsification combined with intraocular lens implantation combined with endoscopic goniosynechialysis (Phaco-IOL-EGSL) in patients with advanced angle-closure glaucoma, and explored the efficacy and risk of the surgery.
Materials and methods Subjects Our objective was to measure the extent of PAS, number of intraocular pressure(IOP) lowering drugs, IOP, BCVA and visual field before and after surgery in patients with advanced PACG, to investigate the efficacy and safety of Phaco-IOL-EGSL. We also evaluate the correlation between the two groups of data.
In this prospective study, consecutive patients with advanced PACG and cataract who underwent Phaco-IOL-EGSL were invited to participate. The study was approved by the Ethics Committee of the Affiliated Eye Hospital of Wenzhou Medical University and informed consent was obtained from all patients, adhered to the tenets of the Declaration of Helsinki. All patients were treated at the Affiliated Eye Hospital of Wenzhou Medical University between February 2014 and March 2016. A total of 17 subjects (19 eyes) were enrolled in the study. Patients were followed up for 12 months. One patient was lost during follow-up, and 16 subjects (18 eyes) were analyzed in this study. No patient refused to participate in the study.
Inclusion and exclusion criteria Inclusion criteria included: a diagnosis of PACG according to the International Society of Geographical \& Epidemiological Ophthalmology (ISGEO) diagnostic criteria,14 visual field score ≥18 calculated (as per the method used in the Advanced Glaucoma Intervention Study [AGIS]), treatment with IOP-lowering drugs for more than 3 months, and mild to moderate cataract. Exclusion criteria included: secondary angle-closure glaucoma and previous history of surgery, except laser peripheral iridotomy.
Preoperative and postoperative examinations Preoperative examinations included: best corrected logMAR visual acuity (BCVA), number of intraocular pressure (IOP) lowering drugs, slit lamp and fundus examination, gonioscopy, Goldmann applanation tonometry and ultrasound biomicroscopy (UBM) (Suowei, Tianjin, China). Visual field tests were conducted with a Humphrey Visual Field Analyzer II (central 30-2 threshold test, size III white stimulus, and SITA-FAST strategy, with the foveal threshold test turned on).
Gonioscopy was performed in a dark room by the same experienced glaucoma specialist (WP) using a Zeiss-style 4-mirror lens (Zeiss Corp, Germany). The examination start with the inferior angle by looking through the superior mirror, the corneal wedge is used to orient oneself to the anatomy.16 The extent of PAS was evaluated by performing indentation gonioscopy around the entire circumference of angle.
All patients were reviewed at 1 week, 1 month, 3 months, 6 months and 12 months after surgery. The number of IOP-lowering drugs and IOP was observed and recorded at each follow-up. The extent of peripheral anterior synechiae , the BCVA and the visual field were recorded at 12 months following surgery.
Surgery procedure All patients used IOP-lowering drugs before surgery; IOP was controlled under 21mmHg where possible. If the preoperative IOP was over 40mmHg a preoperative anterior chamber paracentesis was performed. All surgeries were performed by the same experienced surgeon (WP). Intraoperative and postoperative complications were recorded.
Anaesthesia consisted of topical 0.5% proparacaine and a peribulbar block with bupivacaine. Then conventional phacoemulsification and IOL implantation (CT ASPHINA 509M, Zeiss Corp.) were performed. In all patients, phacoemulsification was performed using the following fluidic parameters: bottle height between 70 and 90 cm, a fixed aspiration flow rate (AFR) of 20 cc/min, and vacuum settings up to 350 mmHg, depending on the grade of nuclear sclerosis. Immediately after implantation of the IOL, a 23G ophthalmic endoscope (OE) probe (URAM E2, USA ENDO OPTIKS) was inserted into the anterior chamber to visualize the PAS through the main incision and side incision. A viscoelastic agent was injected towards the root of the iris where PAS existed (Figure 1A). Then a blunt iris spatula was used to release the areas where PAS remained. The tip was gently moved anteroposterior near the root of the iris in either a clockwise or a counterclockwise direction to release PAS under direct view with the OE (Figure 1B). Both the main incision and a second incision were used to ensure all PAS areas were released. Complete synechialysis was confirmed under the direct view with the OE at the end of the procedure. Using an irrigation and aspiration handpiece from the phaco machine, balanced salt solution replaced the viscoelastic agent. The incision was closed by hydration or sutured with 10-0 nylon if necessary.
Patients used Pranoprofen eye drops (Senju Pharmaceutical Co., Ltd., Japan) and Levofloxacin eye drops (Santen, Japan) four times a day and 0.5% pilocarpine eyedrops (Bausch \& Lomb, America) two times a day for four weeks after the surgery. Patients also used 1% prednisolone acetate eye drops (Allergan Pharmaceuticals, Ireland) four times a day for the first week after the surgery, and then reduced by one drop per week for a total of four weeks.
Success criteria Based on the AGIS study, we defined surgical success as follows: (1) Standard A: IOP<14mmHg using none or one type of IOP-lowering drug; (2) Standard B: IOP <18mmHg using none or one type of IOP-lowering drug.17 Statistical analysis All statistical analyses were performed using SPSS 20.0 statistical software. All data were represented by mean ± standard deviation (SD). The paired t-test was used to evaluate the differences in the extent of PAS, number of IOP lowering drugs, mean deviation , IOP and BCVA. A Spearman rank correlation coefficient was calculated to evaluate the correlation between the two groups of data.18 Statistical significance was set with a P-value <0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cataract surgery with goniosynechialysis | Other | Procedure: Cataract surgery with endoscopic goniosynechialysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- a diagnosis of PACG according to the International Society of Geographical \& Epidemiological Ophthalmology (ISGEO) diagnostic criteria,[14] visual field score ≥18 calculated (as per the method used in the Advanced Glaucoma Intervention Study [AGIS]),[15] treatment with IOP-lowering drugs for more than 3 months, and mild to moderate cataract.
Key exclusion criteria (1 listed)
- secondary angle-closure glaucoma and previous history of surgery, except laser peripheral iridotomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract surgery with endoscopic goniosynechialysisPhacoemulsification was performed first. Immediately after implantation of the IOL, a 23G ophthalmic endoscope (OE) probe was inserted into the anterior chamber to visualize the PAS through the main incision and side incision. A viscoelastic agent and a blunt iris spatula were used to release the areas where where PAS existed. | Procedure or surgery | Cataract surgery with goniosynechialysis |
Primary outcome
The extent of peripheral anterior synechiae (PAS)
Time frame: Change from Baseline PAS at 12 months
observed the the extent of PAS before and after surgery
number of intraocular pressure (IOP) lowering drugs
Time frame: Change from Baseline IOP lowering drugs at 12 months
observed the the number of IOP lowering drugs before and after surgery
IOP
Time frame: Change from Baseline IOP at 12 months
IOP before and after surgery
best corrected visual acuity
Time frame: Change from Baseline best corrected visual acuity at 12 months
best corrected visual acuity before and after surgery
visual field
Time frame: Change from Baseline MD of visual field at 12 months
Mean defect(MD)of visual field before and after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery with endoscopic goniosynechialysis in people with Glaucoma, Closed-Angle, run by Wenzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The extent of peripheral anterior synechiae (PAS) (time frame: Change from Baseline PAS at 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.