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| Name | Class |
|---|---|
| Beijing Tongren Hospital | OTHER |
| Wenzhou Medical University | OTHER |
| The Second Affiliated Hospital of Harbin Medical University | OTHER |
| Huazhong University of Science and Technology |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neodymium:yttrium-aluminum- garnet laser | Device | a neodymium:yttrium-aluminum- garnet laser was used to perform the LPI |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Additional medication or surgery required questionnaire |
| 3 years |
| The change of the best corrected visual acuity after the laser procedure |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiulan zhang, MD,PhD | Contact | zhangxl2@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28302178 | Derived | 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. |
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| OTHER |
| The Third Hospital of HanDan | OTHER |
| Third Affiliated Hospital of Third Military Medical University | OTHER |
| Central South University | OTHER |
| He University | OTHER |
| Hebei Provincial Eye Hospital | OTHER |
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| frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laser | Device | a frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laser was used to perform the LPIP |
|
| Pilocarpine | Drug | 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 LPI | Procedure | 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. |
|
| Proparacaine | Drug | 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 |
|
| LPI | Procedure | 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. |
|
| 3 years |
| The number of the cornea endothelial cells | 3 years |
| The change in angle width and configuration as measured by ultrasound biomicroscopy (UBM) | 3 years |
| ID | Term |
|---|---|
| D015812 | Glaucoma, Angle-Closure |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| D010862 | Pilocarpine |
| C421261 | SLC7A7 protein, human |
| C005717 | proxymetacaine |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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