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Trial History Detail on 2014-10-29

CUHK_CCT00437

2014-10-29

Prospective

2014.377-T

Department of Ophthalmology and Visual Sciences, the Chinese University of Hon Kong

Department of Ophthalmology and Visual Sciences, the Chinese University of Hon Kong

N/A

Miss Wong Sin Ting Janice

3/F, Hong Kong Eye Hospital, 147K, Argyle Street, Mongkok, Kowloon, Hong Kong

39435825

janicewong@cuhk.edu.hk

The Chinese University of Hong Kong

Dr. Jhanji, Vishal

3/F, Hong Kong Eye Hospital, 147K, Argyle Street, Mongkok, Kowloon, Hong Kong

39435807

vishaljhanji@cuhk.edu.hk

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

Efficacy of Collagen Matrix Implant in Pterygium Surgery

Efficacy of Collagen Matrix Implant in Pterygium Surgery

翼狀胬肉手術中Ologen膠原蛋白基質植入的療效

Collagen Matrix Implant in Pterygium Surgery

Hong Kong

Yes

2014-08-04

Pterygium

Device

Ologen device has a rectangular shape with 95% porous space. The pore size ranges from 10 to 300 µm. It comes in dry form consisting of over 90% lyophilized atelo-collagen and less than 10% glycosaminoglycans. Tensile strength is 100 kPa . pH value 7±0.5.
After implantation, the device dissolves slowly and is completely degraded within 90-180 days. The ologen is sterilized using gamma radiation.

One day(Once)

A standard surgical technique for pterygium surgery would be undertaken. Under local anesthesia, pterygium head would be avulsed from the cornea. Tenon’s capsule excision would be undertaken. Subsequently, 0.02% mitomycin C would be applied for 3 minutes under the remaining conjunctiva. A thorough irrigation will be performed with 100 ml of balanced salt solution.

The second group would receive pterygium excision with ologen implantation. Ologen implant would be placed under the conjunctiva and sutures would be placed to retain the implant.

1) Age 18 years or over.
2) Subject who diagnosed with pterygium requiring excision.
3) Subject able and willing to cooperate with investigation plan.
4) Subject able and willing to complete postoperative follow-up requirements.
5) Subject willing to sign informed consent form.

1) Known allergic reaction to collagen.
2) Co-existing ocular infection or inflammation.
3) Pregnant or breast-feeding women.

18 years of age or above

999 years of age

Both Male and Female

Interventional

Randomized

Active

Single-blind

Parallel

2014-11-12

60

Not Yet Recruiting

Pterygium recurrence rate at the end of 12 months postoperatively

• Complications associated with the surgery
• Best-corrected visual acuity at the end of 12 months

No

2016-04-08

ChiCTR-IOR-14005402 

2014-10-30


Yes

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