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

Primary Purpose

Pterygium

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pterygium excision with sutures fixed conjunctival auto-graft
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium focused on measuring pterygium excision, conjunctival auto-graft, ocular irritation, conjunctival hyperemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with pterygium

Exclusion Criteria:

  • Previous ocular surgeries
  • Ocular surface disorders

Sites / Locations

  • Faculty of Medicine, Tanta University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with nasal pterygium.

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 4, 2021
Last Updated
December 18, 2021
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05164900
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
Keywords
pterygium excision, conjunctival auto-graft, ocular irritation, conjunctival hyperemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with nasal pterygium.
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
pterygium excision with sutures fixed conjunctival auto-graft
Intervention Description
Pterygium excision with vicryl 8/0 fixed conjunctival auto-graft under local anesthesia. During the follow up period, indicators of ocular irritation were assessed.
Primary Outcome Measure Information:
Title
Ocular pain was subjectively evaluated.
Description
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.
Time Frame
1 week after surgery.
Title
Change of ocular pain subjective evaluation.
Description
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.
Time Frame
2 weeks, 1 month, 2 and 3 months post-operative.
Title
Ocular foreign body sensation was subjectively evaluated.
Description
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.
Time Frame
1 week after surgery.
Title
Change of ocular foreign body sensation subjective evaluation.
Description
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.
Time Frame
2 weeks, 1 month, 2 and 3 months post-operative.
Title
Watering of the eye was subjectively evaluated.
Description
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.
Time Frame
1 week after surgery.
Title
Change of watering of the eye subjective evaluation.
Description
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.
Time Frame
2 weeks, 1 month, 2 and 3 months post-operative.
Title
The degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated.
Description
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.
Time Frame
2 weeks after surgery.
Title
Change of the degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated.
Description
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.
Time Frame
1month,2 and 3 months post-operative.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with pterygium Exclusion Criteria: Previous ocular surgeries Ocular surface disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Molham Elbakary
Organizational Affiliation
Assitant professor of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Tanta University
City
Tanta
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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