NCT03301974

Brief Summary

Pterygium is a fibrovascular wing shaped encroachment of conjunctival fold on to the cornea with elastotic degeneration of a subconjunctival tissue, The standard treatment for pterygium is surgical excision, but the recurrence rate after surgery can be as high as 24%-89%, which compromises outcomes. Based on the simple excision of pterygium, multiple strategies and techniques have been developed to reduce the high rate of pterygium recurrence. The investigators aim was to compare the safety, efficacy, overall patient satisfaction and recurrence rate of suturing, fibrin gluing and sutureless glue-free technique for attaching conjunctival autograft in primary pterygium surgery.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
1.4 years until next milestone

Study Start

First participant enrolled

February 24, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

9 months

First QC Date

September 27, 2017

Last Update Submit

January 8, 2019

Conditions

Pterygium

Outcome Measures

Primary Outcomes (1)

  • Recurrence Rate

    The main postoperative primary outcomes measure the recurrence rate

    6 months postoperatively

Secondary Outcomes (5)

  • Graft stability

    1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively

  • Postoperative inflammation

    1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively

  • Postoperative discomfort

    1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively

  • Overall patient satisfaction

    1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively

  • Complications

    1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively

Study Arms (3)

conjunctival autograft with fibrin glue

EXPERIMENTAL

Conjunctival autograft with fibrin glue done for patients of group 1 after pterygium excision

Procedure: conjunctival autograft with fibrin glue

sutured conjunctival autograft

EXPERIMENTAL

Sutured conjunctival autograft done for patients of group 2 after pterygium excision

Procedure: sutured conjunctival autograft

sutureless and glue-free conjunctival autograft

EXPERIMENTAL

Sutureless, glue-free conjunctival autograft done for patients of group 3 after pterygium excision

Procedure: sutureless and glue-free conjunctival autograft

Interventions

conjunctival autograft with fibrin gluePROCEDURE

Simple pterygium excision under local anesthesia performed then closure of the bare sclera by fibrin glued conjunctival autograft in 20 eyes of 20 patients (group 1).

conjunctival autograft with fibrin glue
sutured conjunctival autograftPROCEDURE

Simple pterygium excision under local anesthesia performed then closure of the bare sclera by sutured conjunctival autograft in 20 eyes of 20 patients (group 2).

sutured conjunctival autograft
sutureless and glue-free conjunctival autograftPROCEDURE

Simple pterygium excision under local anesthesia performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 20 eyes of 20 patients (group 3)

sutureless and glue-free conjunctival autograft

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients complaining of primary Progressive nasal pterygium.
  • Patients with pterygium threatening the visual axis.

You may not qualify if:

  • Double head pterygium.
  • Pseudopterygium
  • Recurrent pterygium
  • Patients with history of any bleeding abnormalities
  • Patients with ocular surface diseases eg- blepharitis, Sjogren syndrome and dry eye.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pterygium

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist of ophthalmology, El-Mabarah hospital for Health insurance, Assuit, Egypt

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 4, 2017

Study Start

February 24, 2019

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

January 9, 2019

Record last verified: 2019-01