Laser Peripheral Iridotomy Plus Laser Peripheral Iridoplasty for Primary Angle Closure

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

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.

Sponsors & Collaborators

• Beijing Tongren Hospital

  collaborator OTHER

• Wenzhou Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Huazhong University of Science and Technology

  collaborator OTHER

• The Third Hospital of HanDan

  collaborator OTHER

• Third Affiliated Hospital of Third Military Medical University

  collaborator OTHER

• Central South University

  collaborator OTHER

• He University

  collaborator OTHER

• Hebei Provincial Eye Hospital

  collaborator OTHER

• Sun Yat-sen University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-31

Primary Completion

2020-03-31

Completion

2022-04-30

Countries

• China

Study Locations