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Trial History Detail on 2011-02-08

CUHK_CCT00159

2008-04-24

Retrospective

Nil

Nil

Nil

Nil

Ms. Jacqueline Shum

Block B 7/F Staff Quarter The Prince of Wales Hospital Hong Kong

2632-2878

jacqshum@cuhk.edu.hk

Department of Ophthalmology and Visual Science, The Chinese University of Hong Kong

Dr. Kelvin K.L.Chong

Block B 7/F Staff Quarter The Prince of Wales Hospital Hong Kong

2632-2878

email chongkamlung@gmail.com

Department of Ophthalmology and Visual Science, The Chinese University of Hong Kong

Prospective randomized study of silicone stent intubation in endoscopic dacryocysto-rhinostomy for acquired nasolacrimal duct obstruction - SEND study

Prospective randomized study of silicone stent intubation in endoscopic dacryocysto-rhinostomy for acquired nasolacrimal duct obstruction - SEND study

SEND study

Hong Kong

Yes

2006-04-04

Acquired nasolacrimal duct obstruction

Other

Device + procedure

endoscopic dacryocysto-rhinostomy

Stenting: 8 weeks or no stent at all Follow-up: 26 weeks

Endoscopic dacryocystorhinostomy with or without eight weeks bicanalicular silicone intubation

Inclusion criteria 1. Adult patients (>18) with NLDO (on table finding) 2. Informed consent 3. Follow-up to 6 months 4. No previous lacrimal surgery 5. No concomitant canalicular disease 6. Agree for randomization

Exclusion criteria 1. Previous dacryocystorhinostomy 2. Canalicular obstruction requiring membranectomy after sac exposure for free passage of Bowman probe 3. Requiring concomitant punctoplasty procedure

18

n/a

Both Male and Female

Interventional

Randomized

Uncontrolled

Open label

Parallel

2006-04-05

120

Recruiting

% of success achieved in each group at postoperative six months % with formation of granulation tissue at rhinostomy site, time course, response to local debridement and nasal steroid spray

Risk factors analyses for surgical failure or persistence of symptom (age, gender, duration of symptom preoperatively, postoperative tube prolapse, presence of granulation tissue around internal ostium, difficulty intraoperative hemostasis, surgeon's immediate impression, level of surgical experience, endoscopist's assessment postoperatively) Mean time to failure postoperatively (weeks) Complications rate: orbital fat prolapse, epistaxis, infection, tube prolapse, canalicular laceration, synechiae, additional surgery

No

2011-04-01

ChiCTR-TRC-09000721

2010-05-04


Yes

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