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

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT05164900
Collaborator
(none)
25
1
1
15
1.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: pterygium excision with sutures fixed conjunctival auto-graft
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Manifestations of Ocular Irritation Following Pterygium Excision With Sutures Fixed Conjunctival Autograft
Actual Study Start Date :
Jul 1, 2020
Actual Primary Completion Date :
Apr 1, 2021
Actual Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: patients with nasal pterygium.

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients with pterygium
Exclusion Criteria:
  • Previous ocular surgeries

  • Ocular surface disorders

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine, Tanta University Tanta Egypt

Sponsors and Collaborators

  • Tanta University

Investigators

  • Principal Investigator: Molham Elbakary, Assitant professor of Ophthalmology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Molham Abdelhafez Elbakary, Assistant professor of Ophthalmology, Tanta University
ClinicalTrials.gov Identifier:
NCT05164900
Other Study ID Numbers:
  • 34970/10/21
First Posted:
Dec 21, 2021
Last Update Posted:
Dec 21, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Molham Abdelhafez Elbakary, Assistant professor of Ophthalmology, Tanta University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 21, 2021