Clinical trial NCT05164900: Manifestations of Ocular Irritation Following Pterygium Excision With Sutures Fixed Conjunctival Autograft
Official title: Manifestations of Ocular Irritation Following Pterygium Excision With Sutures Fixed Conjunctival Autograft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pterygium
Keywords: pterygium excision
conjunctival auto-graft
ocular irritation
conjunctival hyperemia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this work, the manifestations of ocular irritation associated with vicryl 8/0 sutures fixed conjunctival auto-graft in pterygium patients were evaluated. The severity of post-operative foreign body sensation, pain, and watering was subjectively evaluated. The localized nasal quadrant conjunctival hyperemia was also evaluated. It was found that sutures fixed conjunctival auto-graft can be used safely with short-term minimal to moderate tolerable manifestations of ocular irritation with no significant complications.

Detailed description: All the patients were subjected to pterygium excision surgery with conjunctival auto-graft under local anesthesia. The graft was fixed by vicryl 8-0 sutures.Ocular irritation symptoms including pain, foreign body sensation and watering were subjectively evaluated. Pain was evaluated using 5 points scale, where (0) indicated no pain; (1) very mild easily tolerable pain; (2) mild pain with discomfort; (3) moderate pain that interfered with the usual activities; (4) severe pain that totally interfered with performing daily activities or sleep. Foreign body sensation and watering of the eye were evaluated with the use of a 4 points abnormal sensation scale, where (0) indicated no abnormal sensation; (1) is somewhat bothersome; (2) is moderately bothersome; (3) is very bothersome. The score of patients' subjective symptoms evaluation were collected in a total score which ranged from zero to a maximum of 10. A total score of 3 or less was considered as minimal irritation (grade I), 4-6 was considered as mild-moderate tolerable irritation (grade II), and 7 or more was considered as severe annoying irritation (grade III).

The degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated 2 weeks, 1,2 and 3 months post-operative using the Cornea and Contact Lens Research Unit (CCLRU) photographic grading scale. In this scale 1 refers to very slight; 2 slight; 3 moderate; 4 severe. Decimal fraction of 0.5 was added to describe the intermediate cases.

Eligibility criteria: Inclusion Criteria:

* Patients with pterygium

Exclusion Criteria:

* Previous ocular surgeries
* Ocular surface disorders

Primary outcomes:
measure: Ocular pain was subjectively evaluated.
timeFrame: 1 week after surgery.
measure: Change of ocular pain subjective evaluation.
timeFrame: 2 weeks, 1 month, 2 and 3 months post-operative.
measure: Ocular foreign body sensation was subjectively evaluated.
timeFrame: 1 week after surgery.
measure: Change of ocular foreign body sensation subjective evaluation.
timeFrame: 2 weeks, 1 month, 2 and 3 months post-operative.
measure: Watering of the eye was subjectively evaluated.
timeFrame: 1 week after surgery.
measure: Change of watering of the eye subjective evaluation.
timeFrame: 2 weeks, 1 month, 2 and 3 months post-operative.
measure: The degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated.
timeFrame: 2 weeks after surgery.
measure: Change of the degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated.
timeFrame: 1month,2 and 3 months post-operative.
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine, Tanta University
Study officials:
affiliation: Assitant professor of Ophthalmology
name: Molham Elbakary
role: PRINCIPAL_INVESTIGATOR
References: