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

NCT03686072 | Completed

• 1 other identifier: QZB-HZ-PHACO-EGSL
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (5)

• The extent of peripheral anterior synechiae (PAS)

  observed the the extent of PAS before and after surgery

  Change from Baseline PAS at 12 months

• number of intraocular pressure (IOP) lowering drugs

  observed the the number of IOP lowering drugs before and after surgery

  Change from Baseline IOP lowering drugs at 12 months

• IOP

  IOP before and after surgery

  Change from Baseline IOP at 12 months

• best corrected visual acuity

  best corrected visual acuity before and after surgery

  Change from Baseline best corrected visual acuity at 12 months

• visual field

  Mean defect（MD）of visual field before and after surgery

  Change from Baseline MD of visual field at 12 months

Study Arms (1)

Cataract surgery with goniosynechialysis

OTHER

Procedure: Cataract surgery with endoscopic goniosynechialysis

Interventions

Cataract surgery with endoscopic goniosynechialysis PROCEDURE

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.

Cataract surgery with goniosynechialysis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• secondary angle-closure glaucoma and previous history of surgery, except laser peripheral iridotomy.

Sponsors & Collaborators

• Wenzhou Medical University: lead

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Catract

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 26, 2018
• Study Start: February 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: September 26, 2018

Record last verified: 2018-09