Glaucoma, Angle-ClosureNCT02613013
Laser Peripheral Iridotomy Plus Laser Peripheral Iridoplasty for Primary Angle Closure
A study testing neodymium:yttrium-aluminum- garnet laser, frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laser and Pilocarpine in people with Glaucoma, Angle-Closure, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a 10-centre randomized controlled clinical trial to explore whether laser peripheral iridoplasty (LPIP) plus laser peripheral iridotomy (LPI) is more effective than single LPI to control the progression of primary angle closure with multi-mechanism based on the UBM classification. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Glaucoma, Angle-Closure
- What is being tested?
- neodymium:yttrium-aluminum- garnet laser, frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laser and Pilocarpine
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Apr 2022
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of primary angle closure (PAC), with IOP≤30mmHg and PAS≤270°.
- PAC with multi-mechanism based on UBM examination (multi-mechanism is defined as primary angle closure is caused by pupil block plus at least one kind of non-pupil block factors like (relative anterior position and thick of the ciliary body, the big volume of the iris, the anterior location of the iris insertion into the ciliary body)or any two or more kinds of combination.
- Visual acuity≥ 20/40
- Age between 40-75 years old Chinese people
- If both eyes of a patient are eligible for the study, the e eye had worse visual acuity will be selected. Only one eye per patient is eligible for the study.
- Drug washout:
- Eligible patients who are already on anti-glaucoma medications are required to have drug washout before being randomized. Various medications have different washout periods: Prostaglandin analogues 4 weeks, Beta blockers 3 weeks, Adrenergic agonist 2 weeks, Cholinergic agonist 5 days, Carbonic Anhydrase Inhibitors 5 days. Patients whose IOP>30 mm Hg during this washout period will be stopped from further washout and be withdrawn from the study.
Who cannot join
- Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
- Angle closure due to secondary causes (subluxed lens, neovascular, uveitic, traumatic, post-operative)
- Previous incisional intraocular surgery or ocular laser in study eye (LPI or LPIP, cyclodestructive procedure, cataract surgery)
- Primary angle closure with glaucomatous neuropathy.
- Have cataract in the studying eye and anticipated to have cataract surgery in the coming 3 years; the existing cataract affect visual field examination and fundus examination; the visual acuity <20/40 due to the existing cataract.
- Who are using IOP lowing drugs and do not have drug washout
Show all 16Show fewer
- Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for urgent additional ocular surgery
- Coexisting other ocular diseases (i.e. cornea abnormal or cornea infection, Iridocorneal endothelial syndrome or anterior segment dysgenesis, nanophthalmos, high myopia (>6.0D), Chronic or recurrent uveitis, ocular cancer, trauma, central retinal vein occlusion, central retinal artery occlusion, retinal detachment)
- cornea endothelium counting <1000/mm2
- need local or systemic steroid long-term use
- Unwilling to discontinue contact lens use after surgery
- Who are taking parting in other drug clinical trials
- Pregnant or nursing women
- Severe systemic disease (i.e. diabetes mellitus, hypertension, the end stage of cardiac disease, nephropathy disease, respiratory disease and cancer.
- Allergic to pilocarpine or alcaine
- Contraindication to ocular laser diseases.
Trial locations and contacts
1 site in 1 country.
xiulan zhang, MD,PhD contact
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510060
Xiulan Zhang, MD,PhD, zhangxl2@mail.sysu.edu.cn
Xiulan Zhang, MD,PhD
About this study
Official title: Laser Peripheral Iridotomy Plus Laser Peripheral Iridoplasty for Primary Angle Closure With Multi-mechanism Based on UBM: A Randomized Controlled Trial
This is a 10-centre randomized controlled clinical trial to explore whether laser peripheral iridoplasty (LPIP) plus laser peripheral iridotomy (LPI) is more effective than single LPI to control the progression of primary angle closure with multi-mechanism based on the UBM classification.
- Conditions
- Glaucoma, Angle-Closure
- Being tested
- neodymium:yttrium-aluminum- garnet laser, frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laser, Pilocarpine, LPIP plus LPI, Proparacaine
- 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.
neodymium:yttrium-aluminum- garnet laserDevice
a neodymium:yttrium-aluminum- garnet laser was used to perform the LPI
frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laserDevice
a frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laser was used to perform the LPIP
PilocarpineDrug
30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia (Proparacaine) will be administered
LPIP plus LPIProcedure or surgery
LPIP was applied with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA). 30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia will be administered. Twenty to 30 spots of 250-300 mW power with 300-500 microns of size and duration of 400-500 ms were applied. Power was modified arbitrarily until an effective iris contraction was obtained. Effective iris contraction was considered as a concentric movement around the laser spot, with minimal iris pigmentation and immediate angle opening observed through the lens mirrors using a Goldmann lens. Power was lowered if there was any bursting sound perceived, pigment dispersion, air bubbles or considerable pain. LPI was performed after LPIP procedure.
ProparacaineDrug
30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia (Proparacaine) will be administered
LPIProcedure or surgery
LPI was performed with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA). 30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia (Proparacaine) will be administered. The treatment site was selected in the superior nasal iris or in a crypt, where present. Treatment was initiated with a pulse of 3-5mJ, the power was increased until patency was achieved, the opening of iris >0.1mm. and patency was determined by direct visualization of the posterior chamber.
| Study group | Role | What they receive |
|---|---|---|
| single LPI | Active comparator | LPI was performed with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA). 30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia will be administered. The treatment site was selected in the superior nasal iris or in a crypt, where present. Treatment was initiated with a pulse of 3-5mJ, the power was increased until patency was achieved, the opening of iris >0.1mm. and patency was determined by direct visualization of the posterior chamber. Receives: Device: neodymium:yttrium-aluminum- garnet laser; Drug: Pilocarpine; Drug: Proparacaine; Procedure: LPI |
| LPIP plus LPI | Experimental | LPIP was applied with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA). 30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia will be administered. Twenty to 30 spots of 250-300 mW power with 300-500 microns of size and duration of 400-500 ms were applied. Power was modified arbitrarily until an effective iris contraction was obtained. Effective iris contraction was considered as a concentric movement around the laser spot, with minimal iris pigmentation and immediate angle opening observed through the lens mirrors using a Goldmann lens. Power was lowered if there was any bursting sound perceived, pigment dispersion, air bubbles or considerable pain. LPI was performed after LPIP procedure Receives: Device: neodymium:yttrium-aluminum- garnet laser; Device: frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laser; Drug: Pilocarpine; Procedure: LPIP plus LPI; Drug: Proparacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression rate determined by number of patients who progress after laser treatment for each group.
PAC progression defined as presence of any of the following:
- Acute angle closure crisis
- Intraocular (IOP) was 8mmHg higher than initiation 1 month after the laser procedure
- IOP was ≥22mmHg when measured three times of continuous 1 month after the lase procedure
- The progression of peripheral anterior synechiae ≥ 1 clock hour within 3 years after the laser procedure as measured by gonioscopic examination.
- glaucomatous neuropathy within 3 years after the laser procedure
Measured: 3 years
Secondary outcomes (4)
Additional medication or surgery required questionnaire
- the medication required to control the IOP
- the additional surgery required to control the progression of the PAC
Measured: 3 years
The change of the best corrected visual acuity after the laser procedure
Measured: 3 years
The number of the cornea endothelial cells
Measured: 3 years
The change in angle width and configuration as measured by ultrasound biomicroscopy (UBM)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2020 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Angle-ClosureStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tongren Hospital, Wenzhou Medical University, The Second Affiliated Hospital of Harbin Medical University, Huazhong University of Science and Technology, The Third Hospital of HanDan, Third Affiliated Hospital of Third Military Medical University, Central South University, He University, Hebei Provincial Eye Hospital
- Responsible party
- Principal investigator, xiulan zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613013
- Sponsor's protocol ID
- 2015019
- Status last verified
- Sep 2018
- First submitted
- 5 Nov 2015
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen S, Lv J, Fan S, Zhang H, Xie L, Xu L, Jiang B, Yuan H, Liang Y, Li S, Chen P, Zhang X, Wang N; Multi-mechanism Angle Closure Study (MACs) group. Laser peripheral iridotomy versus laser peripheral iridotomy plus laser peripheral iridoplasty in the treatment of multi-mechanism angle closure: study protocol for a randomized controlled trial. Trials. 2017 Mar 17;18(1):130. doi: 10.1186/s13063-017-1860-4.
PubMed 28302178
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Peripheral Iridotomy Plus Laser Peripheral Iridoplasty for Primary Angle Closure With Multi-mechanism Based on UBM: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02613013
- Acronym / sponsor ID
- 2015019
- Conditions
- Glaucoma, Angle-Closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Beijing Tongren Hospital, Wenzhou Medical University, The Second Affiliated Hospital of Harbin Medical University, Huazhong University of Science and Technology, The Third Hospital of HanDan, Third Affiliated Hospital of Third Military Medical University, Central South University, He University, Hebei Provincial Eye Hospital
- Study start
- Oct 2015
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 24 Nov 2015 (estimated)
- 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.
This is a 10-centre randomized controlled clinical trial to explore whether laser peripheral iridoplasty (LPIP) plus laser peripheral iridotomy (LPI) is more effective than single LPI to control the progression of primary angle closure with multi-mechanism based on the UBM classification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single LPI | Active comparator | Device: neodymium:yttrium-aluminum- garnet laser, Drug: Pilocarpine, Drug: Proparacaine, Procedure: LPILPI was performed with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA). 30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia will be administered. The treatment site was selected in the superior nasal iris or in a crypt, where present. Treatment was initiated with a pulse of 3-5mJ, the power was increased until patency was achieved, the opening of iris >0.1mm. and patency was determined by direct visualization of the posterior chamber. |
| LPIP plus LPI | Experimental | Device: neodymium:yttrium-aluminum- garnet laser, Device: frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laser, Drug: Pilocarpine, Procedure: LPIP plus LPI, Drug: ProparacaineLPIP was applied with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA). 30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia will be administered. Twenty to 30 spots of 250-300 mW power with 300-500 microns of size and duration of 400-500 ms were applied. Power was modified arbitrarily until an effective iris contraction was obtained. Effective iris contraction was considered as a concentric movement around the laser spot, with minimal iris pigmentation and immediate angle opening observed through the lens mirrors using a Goldmann lens. Power was lowered if there was any bursting sound perceived, pigment dispersion, air bubbles or considerable pain. LPI was performed after LPIP procedure |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of primary angle closure (PAC), with IOP≤30mmHg and PAS≤270°.
- PAC with multi-mechanism based on UBM examination (multi-mechanism is defined as primary angle closure is caused by pupil block plus at least one kind of non-pupil block factors like (relative anterior position and thick of the ciliary body, the big volume of the iris, the anterior location of the iris insertion into the ciliary body)or any two or more kinds of combination.
- Visual acuity≥ 20/40
- Age between 40-75 years old Chinese people
- If both eyes of a patient are eligible for the study, the e eye had worse visual acuity will be selected. Only one eye per patient is eligible for the study.
Key exclusion criteria (16 listed)
- Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
- Angle closure due to secondary causes (subluxed lens, neovascular, uveitic, traumatic, post-operative)
- Previous incisional intraocular surgery or ocular laser in study eye (LPI or LPIP, cyclodestructive procedure, cataract surgery)
- Primary angle closure with glaucomatous neuropathy.
- Have cataract in the studying eye and anticipated to have cataract surgery in the coming 3 years; the existing cataract affect visual field examination and fundus examination; the visual acuity <20/40 due to the existing cataract.
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 |
|---|---|---|
| neodymium:yttrium-aluminum- garnet lasera neodymium:yttrium-aluminum- garnet laser was used to perform the LPI | Device | LPIP plus LPI, single LPI |
| frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm lasera frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laser was used to perform the LPIP | Device | LPIP plus LPI |
| Pilocarpine30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia (Proparacaine) will be administered | Drug | LPIP plus LPI, single LPI |
| LPIP plus LPILPIP was applied with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA). 30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia will be administered. Twenty to 30 spots of 250-300 mW power with 300-500 microns of size and duration of 400-500 ms were applied. Power was modified arbitrarily until an effective iris contraction was obtained. Effective iris contraction was considered as a concentric movement around the laser spot, with minimal iris pigmentation and immediate angle opening observed through the lens mirrors using a Goldmann lens. Power was lowered if there was any bursting sound perceived, pigment dispersion, air bubbles or considerable pain. LPI was performed after LPIP procedure. | Procedure or surgery | LPIP plus LPI |
| Proparacaine30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia (Proparacaine) will be administered | Drug | LPIP plus LPI, single LPI |
| LPILPI was performed with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA). 30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia (Proparacaine) will be administered. The treatment site was selected in the superior nasal iris or in a crypt, where present. Treatment was initiated with a pulse of 3-5mJ, the power was increased until patency was achieved, the opening of iris >0.1mm. and patency was determined by direct visualization of the posterior chamber. | Procedure or surgery | single LPI |
Primary outcome
Progression rate determined by number of patients who progress after laser treatment for each group.
Time frame: 3 years
PAC progression defined as presence of any of the following: 1. Acute angle closure crisis 2. Intraocular (IOP) was 8mmHg higher than initiation 1 month after the laser procedure 3. IOP was ≥22mmHg when measured three times of continuous 1 month after the lase procedure 4. The progression of peripheral anterior synechiae ≥ 1 clock hour within 3 years after the laser procedure as measured by gonioscopic examination. 5. glaucomatous neuropathy within 3 years after the laser procedure
4 secondary outcomes
Additional medication or surgery required questionnaire
Time frame: 3 years
The change of the best corrected visual acuity after the laser procedure
Time frame: 3 years
The number of the cornea endothelial cells
Time frame: 3 years
The change in angle width and configuration as measured by ultrasound biomicroscopy (UBM)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Derived from this study: PubMed 28302178Chen S, Lv J, Fan S, Zhang H, Xie L, Xu L, Jiang B, Yuan H, Liang Y, Li S, Chen P, Zhang X, Wang N; Multi-mechanism Angle Closure Study (MACs) group. Laser peripheral iridotomy versus laser peripheral iridotomy plus laser peripheral iridoplasty in the treatment of multi-mechanism angle closure: study protocol for a randomized controlled trial. Trials. 2017 Mar 17;18(1):130. doi: 10.1186/s13063-017-1860-4.
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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.
xiulan zhang, MD,PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neodymium:yttrium-aluminum- garnet laser, frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laser and Pilocarpine in people with Glaucoma, Angle-Closure, run by Sun Yat-sen University at 1 site in China.
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 7 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiulan zhang, MD,PhD (zhangxl2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression rate determined by number of patients who progress after laser treatment for each group. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02613013, which also lists 1 linked publication.
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 6 Sep 2018.