Comparing Phaco/IOL Versus Phaco/IOL + Goniosynechialysis in Subjects With PACG

NCT02376725 | Completed DMC

• 1 other identifier: R796/80/2010
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if phacoemulsification with intraocular lens implant (phaco/IOL) alone or combined with goniosynechialysis is better at controlling intraocular pressure in subjects with primary angle closure.

Conditions

Glaucoma, Angle-closure

Keywords

Goniosynechialysis

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure as measured by Goldmann applanation tonometry

  1 year

Secondary Outcomes (3)

• Per-operative and post-operative complications as determined by the examining/operating clinician

  1 year

• Peripheral anterior synechiae development as measured by gonioscopy

  1 year

• Degree of angle opening as measured by gonioscopy and anterior segment ocular coherence tomography

  1 year

Study Arms (2)

Phaco/IOL

ACTIVE COMPARATOR

Cataract extraction using phacoemulsification technique with intraocular lens implant

Procedure: Phaco/IOL

Phaco/IOL + goniosynechialysis

ACTIVE COMPARATOR

Cataract extraction using phacoemulsification technique with intraocular lens implant with goniosynechialysis

Procedure: Phaco/IOL + goniosynechialysis

Interventions

Phaco/IOL PROCEDURE

Phaco/IOL refers to extracapsular cataract extraction (using phacoemulsification) and intraocular lens implantation

Phaco/IOL

Phaco/IOL + goniosynechialysis PROCEDURE

Phaco/IOL refers to extracapsular cataract ectraction (using phacoemulsification) and intraocular lens implantation. Goniosynechialysis refers to mechanical breaking of peripheral anterior synechiae using a spatula and goniolens to view the drainage angle structures.

Phaco/IOL + goniosynechialysis

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 30 years
• Diagnosis of PAC or PACG. PAC is defined as previous documentation that the posterior trabecular meshwork was not visible for 180 degrees or more with gonioscopy (without indentation) previous to any LPI having been performed and evidence of appositional closure of the drainage angle by the peripheral iris, such as iris pigment in the angle or PAS, or any record of IOP \> 21mmhg. PACG is defined as PAC as above and in addition glaucomatous optic neuropathy. Glaucomatous optic neuropathy is defined as functional and structural evidence of glaucomatous damage consistent with cup-disc ratio (CDR) 0.7 or asymmetry 0.2 between eyes or a neuroretinal rim width 0.1 CDR (at 11-10 or 5-7 0' clock). Glaucomatous field defect is diagnosed with reliable threshold visual field examination of the central 24-2 using Swedish Interactive Threshold Algoritm Standard (SITA-STD) 24-2 strategy, with glaucoma hemifield test results being outside normal limits, and with three or more non-edge contiguous points (except the horizontal nasal meridian) depressed to P\<5%
• IOP \>21 mmHg or ≤ 21 mmHg on topical medication
• More than or equal to 90 degrees of PAS (not necessarily contiguous)
• Lens opacity deemed sufficient to be causing decreased vision in the opinion of the operating surgeon.
• Informed consent

You may not qualify if:

• Previous intraocular surgery (laser iridotomy is allowed)
• Previous eye trauma resulting in documented damage to the drainage angle (such as angle recession)
• For patients on warfarin, International Normalized ratio (INR) \>3.0 on day of surgery
• Evidence of moderate non-proliferative diabetic retinopathy, neovascularization, or rubeosis iridis
• Chronic use of topical or systemic steroids
• Any condition precluding or presumed to preclude reliable visual fields, disc stereo photography, or 12 months of follow up
• Only eye (VA worse than 6/60 Snellen in non-study eye)
• Advanced glaucoma with severe paracentral or generalized field deficit threatening fixation
• Allergic to acetazolamide

Sponsors & Collaborators

• Singapore National Eye Centre: lead
• National Medical Research Council (NMRC), Singapore: collaborator
• Singapore Eye Research Institute: collaborator

Study Sites (1)

Singapore National Eye centre

Singapore, 168751, Singapore

Location

Related Publications (1)

• Husain R, Do T, Lai J, Kitnarong N, Nongpiur ME, Perera SA, Ho CL, Lim SK, Aung T. Efficacy of Phacoemulsification Alone vs Phacoemulsification With Goniosynechialysis in Patients With Primary Angle-Closure Disease: A Randomized Clinical Trial. JAMA Ophthalmol. 2019 Oct 1;137(10):1107-1113. doi: 10.1001/jamaophthalmol.2019.2493.

  PMID: 31294768 DERIVED

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Ophthalmologist

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: March 3, 2015
• Study Start: June 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 3, 2015

Record last verified: 2015-02

Locations

SG (1)