Cauterization Versus ﬁbrin Glue for Conjunctival Autografting in Primary Pterygium Surgery
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|ClinicalTrials.gov Identifier: NCT03321201|
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : May 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pterygium of Conjunctiva and Cornea||Procedure: Cauterization Procedure: Fibrin glue||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||Cauterization Versus ﬁbrin Glue for Conjunctival Autografting in Primary Pterygium Surgery|
|Actual Study Start Date :||May 8, 2018|
|Estimated Primary Completion Date :||May 1, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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.
|Active Comparator: Fibrin glue||
Procedure: Fibrin glue
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.
- Recurrence of pterygium [ Time Frame: 180 days ]Any re-growth of tissue from the area of excision across the limbus onto the cornea.
- Surgical time [ Time Frame: During the surgery ]Surgical time: total operational time required for completion of the operation (measured in minutes)
- Complication rate [ Time Frame: 7, 30 and 180 days ]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
- Pterygium-induced astigmatism [ Time Frame: 7, 30 and 180 days ]Measured as described by Hsu 2014
- Ocular surface condition [ Time Frame: 7, 30 and 180 days ]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.
- Postoperative discomfort, tearing, pain and foreign body sensation [ Time Frame: 7, 30 and 180 days ]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.
- Pain [ Time Frame: 7, 30 and 180 days ]Numerical rating scale (NRS) ranging from 0 to 10, where 0 = No pain and 10 = Pain as intense as you can imagine.
- Economic Analysis [ Time Frame: 180 days ]Cost of each intervention
- Flap time [ Time Frame: During the surgery ]Time needed for preparing and repositioning of the conjunctival grafts (measured in minutes)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03321201
|University Hospital Split||Recruiting|
|Split, Croatia, 21000|
|Contact: Mladen Lesin, MD, PhD 0038521556111 email@example.com|
|Contact 0038521556111 firstname.lastname@example.org|