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

NCT05164900 | Completed

• 1 other identifier: 34970/10/21
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Pterygium

Keywords

pterygium excision; conjunctival auto-graft; ocular irritation; conjunctival hyperemia

Outcome Measures

Primary Outcomes (8)

• Ocular pain was subjectively evaluated.

  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.

  1 week after surgery.

• Change of ocular pain subjective evaluation.

  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.

  2 weeks, 1 month, 2 and 3 months post-operative.

• Ocular foreign body sensation was subjectively evaluated.

  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.

  1 week after surgery.

• Change of ocular foreign body sensation subjective evaluation.

  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.

  2 weeks, 1 month, 2 and 3 months post-operative.

• Watering of the eye was subjectively evaluated.

  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.

  1 week after surgery.

• Change of watering of the eye subjective evaluation.

  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.

  2 weeks, 1 month, 2 and 3 months post-operative.

• The degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated.

  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.

  2 weeks after surgery.

• Change of the degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated.

  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.

  1month,2 and 3 months post-operative.

Study Arms (1)

patients with nasal pterygium.

EXPERIMENTAL

Procedure: pterygium excision with sutures fixed conjunctival auto-graft

Interventions

pterygium excision with sutures fixed conjunctival auto-graft PROCEDURE

Pterygium excision with vicryl 8/0 fixed conjunctival auto-graft under local anesthesia. During the follow up period, indicators of ocular irritation were assessed.

patients with nasal pterygium.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pterygium

You may not qualify if:

• Previous ocular surgeries
• Ocular surface disorders

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine, Tanta University

Tanta, Egypt

Location

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Study Officials

• Molham Elbakary

  Assitant professor of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Ophthalmology

Study Record Dates

• First Submitted: December 4, 2021
• First Posted: December 21, 2021
• Study Start: July 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: October 1, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)