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| Name | Class |
|---|---|
| University Hospital of Split | OTHER |
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Pterygium is a noncancerous growth of the conjunctival tissue over the cornea. It is a progressive disease that may lead to visual impairment in advanced stages, as well as restriction of ocular motility, chronic inflammation and cosmetic concerns. Surgical removal is the treatment of choice, but recurrence of pterygium is a frequent problem. In this randomized controlled cauterization will be compared with fibrin glue for conjunctival autografting in primary pterygium surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cauterization | Experimental |
| |
| Fibrin glue | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cauterization | Procedure | To ensure the stability of the graft during cuttings, four sealing wraps will be installed, which will be removed after cauterisation is completed. Autograft and conjunctiva will be approximated by surgical forceps and will be cauterized using a bipolar cutter (Erbe ICC 50) with a force 1-3 / 20. Forceps will be released slowly to prevent elevation of the graft. The same procedure will be performed 10 times until graft is well firmed. Graft stability will be checked up with a sponge and additional cauterization will be preformed if needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of pterygium | Any re-growth of tissue from the area of excision across the limbus onto the cornea. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical time | Surgical time: total operational time required for completion of the operation (measured in minutes) | During the surgery |
| Complication rate | Complication rate will be analyzed as the occurrence of at least one of the following major complications such as dehiscence, displacement or loss of the autograft, infection, haemorrhage, oedema, fibrosis, retraction and other indications that required special treatment |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Split | Recruiting | Split | 21000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29950464 | Derived | Lesin M, Paradzik M, Marin Lovric J, Olujic I, Ljubic Z, Vucinovic A, Bucan K, Puljak L. Cauterisation versus fibrin glue for conjunctival autografting in primary pterygium surgery (CAGE CUP): study protocol of a randomised controlled trial. BMJ Open. 2018 Jun 27;8(6):e020714. doi: 10.1136/bmjopen-2017-020714. |
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Anonymized individual participant data will be made available to other researchers on request.
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| ID | Term |
|---|---|
| C566740 | Pterygium Of Conjunctiva And Cornea |
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| ID | Term |
|---|---|
| D002425 | Cautery |
| D015718 | Fibrin Tissue Adhesive |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D005337 | Fibrin |
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Surgeons will not be blinded. All the other investigators, as well as study participants, outcome assessors and author that will analyze the data will be blinded.
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| Fibrin glue | Procedure | Fiber adhesive (Tissel 1 mL kit4-iu) will be prepared according to manufacturer's instructions. Preparation time will be approximately 10-15 min per kit. Once mixed the fibrin glue is usable up to 4 h. For the purpose of the study preparation of the fibrin glue will be performed by a nurse. |
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| 7, 30 and 180 days |
| Pterygium-induced astigmatism | Measured as described by Hsu 2014 | 7, 30 and 180 days |
| Ocular surface condition | The Ocular Surface Disease Index (OSDI) is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates a perceived improvement in ocular comfort. | 7, 30 and 180 days |
| Postoperative discomfort, tearing, pain and foreign body sensation | Using modified scale from Lim Bon Siong et al: (0) none, no pain, (1) very mild, (2) mild, pain causing some discomfort, (3) moderate, pain that partially interferes with usual activity or sleep, (4) sever, pain that completely interferes with usual activity or sleep. | 7, 30 and 180 days |
| Pain | Numerical rating scale (NRS) ranging from 0 to 10, where 0 = No pain and 10 = Pain as intense as you can imagine. | 7, 30 and 180 days |
| Economic Analysis | Cost of each intervention | 180 days |
| Flap time | Time needed for preparing and repositioning of the conjunctival grafts (measured in minutes) | During the surgery |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |