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Cataract Surgery Combined With Endoscopic Goniosynechialysis for Advanced Primary Angle Closure Glaucoma

NCT03686072 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2018-09-26

No results posted yet for this study

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) 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.

Conditions

  • Glaucoma, Closed-Angle

Interventions

PROCEDURE

Cataract surgery with endoscopic goniosynechialysis

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.

Sponsors & Collaborators

  • Wenzhou Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-09-30
Completion
2017-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03686072 on ClinicalTrials.gov