Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-31 @ 4:00 PM
Study NCT ID:
NCT05164900
Status:
COMPLETED
Last Update Posted:
2021-12-21
First Post:
2021-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Manifestations of Ocular Irritation Following Pterygium Excision With Sutures Fixed Conjunctival Autograft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011625', 'term': 'Pterygium'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-18', 'studyFirstSubmitDate': '2021-12-04', 'studyFirstSubmitQcDate': '2021-12-18', 'lastUpdatePostDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular pain was subjectively evaluated.', 'timeFrame': '1 week after surgery.', '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.'}, {'measure': 'Change of ocular pain subjective evaluation.', 'timeFrame': '2 weeks, 1 month, 2 and 3 months post-operative.', '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.'}, {'measure': 'Ocular foreign body sensation was subjectively evaluated.', 'timeFrame': '1 week after surgery.', '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.'}, {'measure': 'Change of ocular foreign body sensation subjective evaluation.', 'timeFrame': '2 weeks, 1 month, 2 and 3 months post-operative.', '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.'}, {'measure': 'Watering of the eye was subjectively evaluated.', 'timeFrame': '1 week after surgery.', '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.'}, {'measure': 'Change of watering of the eye subjective evaluation.', 'timeFrame': '2 weeks, 1 month, 2 and 3 months post-operative.', '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.'}, {'measure': 'The degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated.', 'timeFrame': '2 weeks after surgery.', '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.'}, {'measure': 'Change of the degree of localized conjunctival hyperemia involving the nasal quadrant was evaluated.', 'timeFrame': '1month,2 and 3 months post-operative.', '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pterygium excision', 'conjunctival auto-graft', 'ocular irritation', 'conjunctival hyperemia'], 'conditions': ['Pterygium']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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).\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with pterygium\n\nExclusion Criteria:\n\n* Previous ocular surgeries\n* Ocular surface disorders'}, 'identificationModule': {'nctId': 'NCT05164900', 'briefTitle': 'Manifestations of Ocular Irritation Following Pterygium Excision With Sutures Fixed Conjunctival Autograft', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Manifestations of Ocular Irritation Following Pterygium Excision With Sutures Fixed Conjunctival Autograft', 'orgStudyIdInfo': {'id': '34970/10/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with nasal pterygium.', 'interventionNames': ['Procedure: pterygium excision with sutures fixed conjunctival auto-graft']}], 'interventions': [{'name': 'pterygium excision with sutures fixed conjunctival auto-graft', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['patients with nasal pterygium.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Molham Elbakary', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assitant professor of Ophthalmology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of Ophthalmology', 'investigatorFullName': 'Molham Abdelhafez Elbakary', 'investigatorAffiliation': 'Tanta University'}}}}