Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00326560
Other study ID # CEN/06/03/021
Secondary ID
Status Recruiting
Phase Phase 3
First received May 15, 2006
Last updated June 15, 2006
Start date May 2006
Est. completion date September 2007

Study information

Verified date May 2006
Source Wellington Hospital
Contact Reece C Hall, MBChB
Phone 0064 4 3855999
Email reece.hall@ccdhb.org.nz
Is FDA regulated No
Health authority New Zealand: Health and Disability Ethics Committees
Study type Interventional

Clinical Trial Summary

Pterygium excision surgery involves excising the abnormal growth from the cornea and filling the defect with a conjunctival (white of the eye) graft from the superior part of the eye. This is the best method of pterygium excision but it is recognised that in 10-15% of cases it will grow back (recurrence). Currently the investigators use small sutures to sew the graft in place. Recently it has been described that glue can be used instead of the sutures. It has been shown in one study that the patient discomfort is less and so is the surgical time. The investigators want to confirm these findings and also compare the recurrence rate between the two types of surgery. They plan to complete a prospective, randomised, control trial of 40 participants. Twenty will have traditional pterygium surgery with the conjunctival autograft sutured. Twenty will have cut and paste surgery with Tisseel glue. The two groups of participants will be compared for pain and discomfort, surgery time, and recurrence rate of the pterygia.


Description:

This is a prospective, randomised, control trial of 40 participants. Twenty patients in each arm. Twenty patients undergo standard pterygium excision with the conjunctival autograft sutured. Twenty patients undergo pterygium surgery with Tisseel glue replacing sutures as a method of attaching the conjunctival autograft. Participants will be reviewed, selected, and consented on a pre-assessment day. Surgery will be performed 10 at a time on an all day surgery operating list. Randomisation of the surgery type will be done at the time of surgery after the pterygium has been excised and the autograft taken. One surgeon (R. Hall) will perform all of the procedures. Follow-up will occur at week 1, 2, 4, 26, 52. A questionnaire answered by participants will indicate their pain, foreign body sensation, tearing, and discomfort. There will be observation of any complications such as graft failure and recurrence rate. Photographs will be taken pre-op and post-op.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Primary pterygium

Exclusion Criteria:

- Ocular surface disease

- Previous pterygium surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Pterygium excision and conjunctival autograft


Locations

Country Name City State
New Zealand Wellington Ophthalmology Department, Capital Coast District Health Board Wellington

Sponsors (2)

Lead Sponsor Collaborator
Wellington Hospital Baxter Healthcare Corporation

Country where clinical trial is conducted

New Zealand, 

References & Publications (3)

Koranyi G, Seregard S, Kopp ED. Cut and paste: a no suture, small incision approach to pterygium surgery. Br J Ophthalmol. 2004 Jul;88(7):911-4. — View Citation

Koranyi G, Seregard S, Kopp ED. The cut-and-paste method for primary pterygium surgery: long-term follow-up. Acta Ophthalmol Scand. 2005 Jun;83(3):298-301. — View Citation

Uy HS, Reyes JM, Flores JD, Lim-Bon-Siong R. Comparison of fibrin glue and sutures for attaching conjunctival autografts after pterygium excision. Ophthalmology. 2005 Apr;112(4):667-71. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Surgery time
Primary Patient discomfort at day one, week one, two, four
Primary Recurrence rate at months three, six, twelve
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02641132 - Pterygium Head Body MMC1: Two Different Surgical Procedures and Their Effect on Endothelial Cell Count. Phase 4
Completed NCT02342392 - Intralesional Ranibizumab on Pterygium Vascularity, Size and Recurrence Rate: a Pilot Study Phase 2/Phase 3
Recruiting NCT01387971 - Using Impression Cytology to Observe the Cytological Changes of Ocular Surface Cells in Various Ocular Surface Disorders N/A
Recruiting NCT05978687 - The Use of Lidocaine Gel Versus Subconjunctival Xylocaine Injection in Pterygium Excision Phase 4
Not yet recruiting NCT06042296 - Expression of CD44, PCNA and E-cadherin in Pterygium Tissue
Completed NCT04022811 - Effect of Bromfenac on Pain Related to Pterygium Surgery Phase 4
Recruiting NCT01261455 - Prospective Randomized Pilot Study Comparing Inferior Versus Superior Conjunctival Autografts for Primary Pterygia N/A
Recruiting NCT01249235 - Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery N/A
Completed NCT01115517 - Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery Phase 2
Completed NCT00768963 - Ranibizumab for the Inhibition of Neovascularization in Pterygia Phase 1
Completed NCT00949728 - Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia N/A
Recruiting NCT00563277 - Surgical Treatment of Concurrent Cataract and Primary Pterygium N/A
Completed NCT00346450 - Autologous ex Vivo Conjunctival Epithelial Cell Expansion for Ocular Surface Transplantation Phase 3
Completed NCT03533244 - A Study of the Response to AG-86893 in Patients With Pterygium Hyperemia Phase 2
Completed NCT04403516 - Dextenza in Pterygium Surgery Phase 4
Recruiting NCT02911532 - Tissue Engineering Conjunctiva for the Treatment of Pterygium and Atretoblepharia N/A
Not yet recruiting NCT03304366 - Corneal Changes With Pentacam Before and After Pterygium N/A
Unknown status NCT02015000 - Surgical Result of Pterygium Extended Removal Followed by Fibrin Glue Assisted Amniotic Membrane Transplantation N/A
Completed NCT00344201 - Assessment of Fibrin Glue in Pterygium Surgery and Other Forms of External Eye Surgery Phase 1
Not yet recruiting NCT03314389 - The Corneal and Conjunctiva Sensation Before and After Pterygium Surgeries N/A