Manifestations of Ocular Irritation Following Pterygium Excision With Sutures Fixed Conjunctival Autograft

Not Applicable

Completed

• Conditions: Pterygium
• Interventions: Procedure: pterygium excision with sutures fixed conjunctival auto-graft

• Registration Number: NCT05164900
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2021-04-01
• Study Completion: 2021-10-01
• Status Verified: 2021-12
• Study First Submitted: 2021-12-04
• Study First Submitted QC: 2021-12-18
• Last Update Submitted: 2021-12-18
• Study First Posted: 2021-12-21
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patients with pterygium

Exclusion Criteria

• Previous ocular surgeries
• Ocular surface disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with nasal pterygium.	pterygium excision with sutures fixed conjunctival auto-graft	-

Primary Outcome Measures

Name	Time	Method
Ocular foreign body sensation was subjectively evaluated.	1 week after surgery.	Foreign body sensation was 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.
Change of ocular foreign body sensation subjective evaluation.	2 weeks, 1 month, 2 and 3 months post-operative.	Foreign body sensation was 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.
Ocular pain was subjectively evaluated.	1 week after surgery.	The 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.
Watering of the eye was subjectively evaluated.	1 week after surgery.	Watering of the eye was 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.
Change of watering of the eye subjective evaluation.	2 weeks, 1 month, 2 and 3 months post-operative.	Watering of the eye was 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.
Change of the degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated.	1month,2 and 3 months post-operative.	The degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated 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.
The degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated.	2 weeks after surgery.	The degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated 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.
Change of ocular pain subjective evaluation.	2 weeks, 1 month, 2 and 3 months post-operative.	The 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.

Trial Locations

Locations (1)

Faculty of Medicine, Tanta University; 🇪🇬 Tanta, Egypt