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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sutures | Active Comparator | After pterygium removal the conjunctival graft to cover bare sclera will be secured with interrupted 8.0 polyglactin sutures. |
|
| Cautery | Experimental | After pterygium removal the conjunctival graft to cover bare sclera will be secured with bipolar electrocautery, power set at 25 until whitening of tissue observed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cautery | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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;
| Day 1 |
| 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;
| Week 1 |
| 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;
| Week 2 |
| 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;
|
| Measure | Description | Time Frame |
|---|---|---|
| Operating time | Analysis. start time of operation, start time of conjunctival graft attachment and end time of operation will be recorded. | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Recurrence |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim N Jebodhsingh, MBBS, DABO | The Queen Elizabeth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital | Bridgetown | Barbados |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 29, 2017 | |
| Reset | Aug 9, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 29, 2017 | Aug 9, 2018 |
| ID | Term |
|---|---|
| D011625 | Pterygium |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002425 | Cautery |
| D013537 | Sutures |
| D011098 | Polyglactin 910 |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D053831 | Surgical Fixation Devices |
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|
|
| Sutures | Procedure |
|
|
|
| Week 3 |
| 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;
| Week 7 |
| 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;
| 3 months |
Any regrowth of the pterygium onto the cornea will be considered a recurrence
| 1 year |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D011091 | Polyesters |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |