NCT02613013

Laser Peripheral Iridotomy Plus Laser Peripheral Iridoplasty for Primary Angle Closure

Laser Peripheral Iridotomy Plus Laser Peripheral Iridoplasty for Primary Angle Closure With Multi-mechanism Based on UBM: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma, Angle-Closure

Interventions

Type	Name	Description
DEVICE	neodymium:yttrium-aluminum- garnet laser	a neodymium:yttrium-aluminum- garnet laser was used to perform the LPI
DEVICE	frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laser	a frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laser was used to perform the LPIP
DRUG	Pilocarpine	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
PROCEDURE	LPIP plus LPI	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.
DRUG	Proparacaine	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
PROCEDURE	LPI	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.

Timeline

• Start date: 2015-10-01
• Primary completion: 2020-03-01
• Completion: 2022-04-01
• First posted: 2015-11-24
• Last updated: 2018-09-06

Locations

1 site across 1 country: China