Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00437

2 Trial Registration Date

2014-10-29

i Registration Status

Prospective

3 Secondary IDs

2014.377-T

4 Source(s) of Funding

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

5 Primary Sponsor

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

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Miss Wong Sin Ting Janice

ii Address

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

iii Phone

39435825

iv Email

janicewong@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr. Jhanji, Vishal

ii Address

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

iii Phone

39435807

iv Email

vishaljhanji@cuhk.edu.hk

v Affiliation

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

vi Country

9 Official Scientific Title of the Study

Efficacy of Collagen Matrix Implant in Pterygium Surgery

10 Public Title

Efficacy of Collagen Matrix Implant in Pterygium Surgery

i Public Title in Chinese 研究名稱

翼狀胬肉手術中Ologen膠原蛋白基質植入的療效

11 Short Title (Optional)

Collagen Matrix Implant in Pterygium Surgery

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-08-04

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Pterygium

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

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.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

One day(Once)

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

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.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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.

ii Exclusion Criteria

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

iii Age Minimum

18 years of age or above

iv Age Maximum

999 years of age

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-11-12

21 Target Sample Size

60

22 Recruitment Status

Unknown

23 Primary Outcome

Pterygium recurrence rate at the end of 12 months postoperatively

24 Secondary Outcome

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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-04-08

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-14005402

28 Date of Registration in Primary Registry

2014-10-30

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Trial History Detail on 2015-11-28