Pterygium of Conjunctiva and Cornea
Conditions
Brief summary
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.
Interventions
PROCEDURECauterization
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.
PROCEDUREFibrin 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.
Sponsors
University Hospital of Split
University of Split, School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adults (older than 18 years of age) * both sexes * primary nasal pterygia ˃4 mm, which tends to increase, including patients with reduced visual acuity, chronic inflammation, cosmetic reasons * if the patients had a bilateral pterygium, only one eye will be operated
Exclusion criteria
* connective tissue disease * prior eye surgery * chronic use of topical drugs (anti-glaucoma drugs)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of pterygium | 180 days | Any re-growth of tissue from the area of excision across the limbus onto the cornea. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical time | During the surgery | Surgical time: total operational time required for completion of the operation (measured in minutes) |
| Complication rate | 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 | 7, 30 and 180 days | Measured as described by Hsu 2014 |
| Ocular surface condition | 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 | 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 | 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 | 180 days | Cost of each intervention |
| Flap time | During the surgery | Time needed for preparing and repositioning of the conjunctival grafts (measured in minutes) |
Countries
Croatia
Outcome results
None listed