Clinical Trials Logo

Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT02321150
Other study ID # KJebodhsingh
Secondary ID
Status Unknown status
Phase N/A
First received December 3, 2014
Last updated December 26, 2014
Start date December 2013
Est. completion date December 2014

Study information

Verified date December 2014
Source The University of The West Indies
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to introduce a new surgical technique for the removal of pterygiums that entails the use of bipolar electrocautery to secure the graft, rather than sutures.

With this, the objective is to evaluate the benefits of a new technique for pterygium surgery with respect to postoperative patient comfort, surgery time, cost and recurrence rate.


Recruitment information / eligibility

Status Unknown status
Enrollment 50
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with one or more pterygiums over age 18

Exclusion Criteria:

- Patients with glaucoma

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Cautery
Pterygium dissected off, corneal bed burred smooth and autograft harvested as per usual technique. Conjunctiva undermined at the recipient site. Relaxing incisions placed at the corners of the recipient site. Graft is slid into place Graft / host interface is gently dried with a Qtip Bipolar cautery is applied after grasping the graft and host conjunctiva gently between cautery forceps. Power setting: 25. Duration of cautery: 4 -5 seconds; the tissue should whiten and contract as desiccation and coagulation take place. Some charring may occur. Counter traction is applied to the conjunctiva as the cautery forceps are gently teased off Cautery is applied at the 4 apices of the graft then in between these points.
Sutures
Pterygium dissected off, corneal bed burred smooth and autograft harvested as per usual technique. Conjunctiva undermined at the recipient site. Graft is slid into place The graft is secured to host conjunctiva using 7 interrupted sutures

Locations

Country Name City State
Barbados Queen Elizabeth Hospital Bridgetown

Sponsors (1)

Lead Sponsor Collaborator
The University of The West Indies

Country where clinical trial is conducted

Barbados, 

Outcome

Type Measure Description Time frame Safety issue
Other Operating Cost Cost Benefit Analysis. Total cost of pterygium surgery using sutures for graft attachment versus cost using cautery for graft attachment will be calculated and compared. day 1
Other Recurrence Any regrowth of the pterygium onto the cornea will be considered a recurrence 1 year
Primary Patient Discomfort Grading of patients' symptoms (pain, foreign body sensation, irritation, and epiphora) will be done using a 5-point scale. The scale ranges from 0 to 4:
0 = no symptom at all;
= presence of the symptom but easily tolerated;
= presence of the symptom causing some discomfort;
= presence of the symptom causing discomfort that interferes with usual activity or sleep;
= presence of the symptom that completely interferes with usual activity or sleep.
Day 1
Primary Patient Discomfort Grading of patients' symptoms (pain, foreign body sensation, irritation, and epiphora) will be done using a 5-point scale. The scale ranges from 0 to 4:
0 = no symptom at all;
= presence of the symptom but easily tolerated;
= presence of the symptom causing some discomfort;
= presence of the symptom causing discomfort that interferes with usual activity or sleep;
= presence of the symptom that completely interferes with usual activity or sleep.
Week 1
Primary Patient Discomfort Grading of patients' symptoms (pain, foreign body sensation, irritation, and epiphora) will be done using a 5-point scale. The scale ranges from 0 to 4:
0 = no symptom at all;
= presence of the symptom but easily tolerated;
= presence of the symptom causing some discomfort;
= presence of the symptom causing discomfort that interferes with usual activity or sleep;
= presence of the symptom that completely interferes with usual activity or sleep.
Week 2
Primary Patient Discomfort Grading of patients' symptoms (pain, foreign body sensation, irritation, and epiphora) will be done using a 5-point scale. The scale ranges from 0 to 4:
0 = no symptom at all;
= presence of the symptom but easily tolerated;
= presence of the symptom causing some discomfort;
= presence of the symptom causing discomfort that interferes with usual activity or sleep;
= presence of the symptom that completely interferes with usual activity or sleep.
Week 3
Primary Patient Discomfort Grading of patients' symptoms (pain, foreign body sensation, irritation, and epiphora) will be done using a 5-point scale. The scale ranges from 0 to 4:
0 = no symptom at all;
= presence of the symptom but easily tolerated;
= presence of the symptom causing some discomfort;
= presence of the symptom causing discomfort that interferes with usual activity or sleep;
= presence of the symptom that completely interferes with usual activity or sleep.
Week 7
Primary Patient Discomfort Grading of patients' symptoms (pain, foreign body sensation, irritation, and epiphora) will be done using a 5-point scale. The scale ranges from 0 to 4:
0 = no symptom at all;
= presence of the symptom but easily tolerated;
= presence of the symptom causing some discomfort;
= presence of the symptom causing discomfort that interferes with usual activity or sleep;
= presence of the symptom that completely interferes with usual activity or sleep.
3 months
Secondary Operating time Analysis. start time of operation, start time of conjunctival graft attachment and end time of operation will be recorded. day 1
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
Recruiting NCT00326560 - Comparison of Glue With Sutures for Pterygium Surgery Phase 3