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Trial History Detail on 2012-04-26

CUHK_CCT00043

2005-09-08

Retrospective

CUHK Direct Grant

n/a

n/a

Prof. Clement CY Tham

Dept. of Ophthalmology & Visual Sciences, Hong Kong Eye Hospital

2762 3196

clemtham@hkstar.com

The Chinese University of Hong Kong

Prof. Clement CY Tham

Dept. of Ophthalmology & Visual Sciences, Hong Kong Eye Hospital

2762 3196

clemtham@hkstar.com

The Chinese University of Hong Kong

A randomized controlled trial to compare cataract extraction alone by phacoemulsification versus combined phaco-trabeculectomy in the treatment of chronic angle-closure glaucoma (CACG) with coexisting cataract.

A randomized controlled trial to compare cataract extraction alone by phacoemulsification versus combined phaco-trabeculectomy in the treatment of chronic angle-closure glaucoma (CACG) with coexisting cataract.

Hong Kong

Yes

2003-08-05

Eye Diseases

Procedure

Cataract extraction by Phacoemulsification

30 to 45 minutes

Combined Phaco-trabeculectomy

Inclusion Criteria 1. Eyes with CACG and coexisting cataract as defined above 2. Patient able and willing to give informed consent to phacoemulsification or phaco-TBx, prior to randomization

Exclusion criteria 1. Single functional eye 2. Eyes with very advanced glaucomatous damage, defined as visual field loss threatening fixation, or cup-to-disc ratio of 0.9 and above 3. Patients refusing either cataract extraction or trabeculectomy 4. Previous intraocular surgery, with the exception of laser peripheral iridotomy and argon laser peripheral iridoplasty (ALPI).

n / a

n / a

Both Male and Female

Interventional

Randomized

Active

Open label

Parallel

2003-08-05

150

Complete

IOP

1. Number of IOP-lowering medications 2. Anesthetic method required, anesthetic complications, and subjective pain score by visual-analog scale 3. Peri-operative complications 4. Operative time, and Total operative time (including second-staged trabeculectomy performed for phaco-alone patients whose IOP is not sufficiently controlled, any other additional glaucoma procedures to further control IOP, and any procedures to handle complications of surgery) 5. Visual acuity (VA) 6. Angle status by indentation gonioscopy and ultrasound biomicroscopy (UBM) 7. Change in visual field by automated perimetry (Humphrey's) 8. Change in vertical cup-to-disc ratio of the optic nerve head 9. Rate of aqueous outflow by pneumatonometer measurements 10. Quality of Life (QOL) 11. Cost-effective analysis - including any additional procedures required to control IOP and cost of glaucoma drugs

No

2012-04-26

ChiCTR-TRC-09000642

2010-05-04


Yes

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