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

NCT ID: NCT05164900

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-10-01

Brief Summary

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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

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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.

Conditions

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Pterygium

Keywords

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pterygium excision conjunctival auto-graft ocular irritation conjunctival hyperemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patients with nasal pterygium.

Group Type EXPERIMENTAL

pterygium excision with sutures fixed conjunctival auto-graft

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with pterygium

Exclusion Criteria

* Previous ocular surgeries
* Ocular surface disorders
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Molham Abdelhafez Elbakary

Assistant professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Molham Elbakary

Role: PRINCIPAL_INVESTIGATOR

Assitant professor of Ophthalmology

Locations

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Faculty of Medicine, Tanta University

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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34970/10/21

Identifier Type: -

Identifier Source: org_study_id