Clinical Trial: Strategies for Management of Recurrent Pterygium

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Management of Recurrent Pterygium to Prevent Visual Impairment

Brief Summary:

Pterygium is a common eye disease. Its mechanism remains unknown but studies suggest that it is related to exposure to ultraviolet rays and ocular dryness. Pterygium affects vision by causing astigmatism and may encroach on cornea (transparent part of the eye) affecting vision. It could cause ocular irritation and can be cosmetically unacceptable especially when inflamed.

Recurrence is the most common outcome of pterygium excision. Recurrence rates of pterygium vary from 10 to more than 80%. Recurrence can be detected first in the conjunctiva(skin of your eye), before advancing on to the cornea. Treating the recurrent pterygium before the cornea gets involved avoids repeat surgery, which is difficult and is associated with more scarring. To avoid repeated surgeries, the activity of a recurrent pterygium should be stopped before it progresses to true recurrence.

Several studies attributed the recurrence pf pterygium to the increase of substances as vascular endothelial growth factor(VEGF) and fibroblast growth factor. Avastin (Anti-VEGF) and 5 fluorouracil(5FU) (antimetabolite) are medications that suppress the formation of VEGF and fibroblast growth factor.

Studies have shown that the subconjunctival injection of 5 F and Avastin into the recurring pterygium has been both safe and effective in treatment of recurrent pterygium.

In many cases, vascularization and inflammation were controlled by subconjunctival Avastin, providing evidence for a role of VEGF in pterygium formation. 5FU is widely used in ophthalmology because of its anti-scarring properties.

The other option for treatment of recurrent pterygium is surgery. Recurrent pterygium is a challenging condition that usually

Detailed Summary:

Purpose To assess the efficacy of combined 5FU and Avastin injections in the treatment of recurrent pterygium.

Design Pilot study. The patients will receive combined 5FU and Avastin injection.

Methodology Patients for inclusion in the study will be identified in the specialist corneal clinics at Queens Medical Centre.

5 FU injection

Dose: 0.15 ml of 5FU (3.75mg) will be administered into the body of the recurring pterygium up to 5 injections as determined by response. The 5FU solution is prepared locally in the pharmacy for ophthalmic use. It will be delivered preloaded in a 1ml syringe containing 0.3 ml of 2.5mg 5FU per 0.1ml. The injection will be given under topical anaesthesia. One to two drops of 5% povidone iodine will be instilled in the conjunctival sac 5min before the injection. All injections will be given in the outpatient clinic using a slit lamp. The needle (27Gauge) will be advanced in a zigzag manner into the subconjunctival space, avoiding any large blood vessels, until the middle of the lesion is reached. The solution will be then injected and the needle withdrawn. After the injection, 1-2 drops of chloramphenicol 0.5% preservative free minims will be instilled topically and continued four times a day for 3 days after each injection. Injections will be carried out every two weeks as described above. Patients will have the ability to access the 24 hour on call emergency eye service, and at the same time be provided with contact numbers for investigators for any queries during the study period.

Avastin injection

Dose: 0.15 ml of Avastin (2.5 mg/0.1 ml) will be administered in the body of the recurrent lesion. Up
Sponsor: University of Nottingham

Current Primary Outcome: Arrest of progression of the fibrovascular tissue will be measured using slit lamp (width of the lesion in millimeters) [ Time Frame: At 3 month, which is 2 weeks after the last injection ]

The width of the lesion will be measured on slit lamp in millimeters


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Disappearance of redness of the lesion will be assessed using the slit lamp [ Time Frame: At 3 month, which is 2 weeks after the last injection ]
    Images will be taken using anterior segment slit lamp camera and will be compared for redness by 2 different observers
  • Return of conjunctiva to normal thickness will be measured using slit lamp (millimeters) [ Time Frame: At 3 month, which is 2 weeks after the last injection ]
    The thicknessof the lesion will be measured on slit lamp in millimeters


Original Secondary Outcome: Same as current

Information By: University of Nottingham

Dates:
Date Received: August 18, 2015
Date Started: September 2015
Date Completion: August 2018
Last Updated: August 20, 2015
Last Verified: August 2015