Comparison of Glue With Sutures for Pterygium Surgery

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Pterygium

Clinical Trial Details

NCT number	NCT00326560
Study type	Interventional
Source	Wellington Hospital
Contact	Reece C Hall, MBChB
Phone	0064 4 3855999
Email	reece.hall@ccdhb.org.nz
Status	Recruiting
Phase	Phase 3
Start date	May 2006
Completion date	September 2007

View Details

See also
Status	Clinical Trial	Phase
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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	`NCT01249235` - Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery	N/A
Recruiting	`NCT01261455` - Prospective Randomized Pilot Study Comparing Inferior Versus Superior Conjunctival Autografts for Primary Pterygia	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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.