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A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery

NCT03301974 — Not applicable, Unknown, 60 participants, Assiut University
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RegistryNCT03301974
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment60 (Estimated)
SponsorAssiut University (Other)
ConditionsPterygium
Interventionsconjunctival autograft with fibrin glue, sutured conjunctival autograft, sutureless and glue-free conjunctival autograft (Procedure)
Datesstart 2019-02-24 (estimated), primary completion 2019-12-01 (estimated), completion 2020-01-01 (estimated), first posted 2017-10-04, last updated 2019-01-09

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-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.

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+Detailed description

Design: Prospective randomized comparative interventional clinical study Setting: Assiut university hospital \& El-Mabarah hospital for health insurance Methods: The study included 60 eyes of 60 consecutive patients of primary nasal pterygium were enrolled in the study. Simple excision under local anesthesia was performed then closure of the bare sclera by conjunctival autograft with fibrin glue in 20 eyes of 20 patients (group 1), versus sutured free conjunctival autograft in 20 eyes of 20 patients (group 2) ), versus sutureless and glue-free conjunctival autograft in 20 eyes of 20 patients (group 3).

+Arms and interventions

ArmTypeInterventionsDescription
conjunctival autograft with fibrin glueExperimentalProcedure: conjunctival autograft with fibrin glueConjunctival autograft with fibrin glue done for patients of group 1 after pterygium excision
sutured conjunctival autograftExperimentalProcedure: sutured conjunctival autograftSutured conjunctival autograft done for patients of group 2 after pterygium excision
sutureless and glue-free conjunctival autograftExperimentalProcedure: sutureless and glue-free conjunctival autograftSutureless, glue-free conjunctival autograft done for patients of group 3 after pterygium excision
  • conjunctival autograft with fibrin glue (Procedure): 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).
  • sutured conjunctival autograft (Procedure): 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).
  • sutureless and glue-free conjunctival autograft (Procedure): 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)

+Outcome measures

Primary outcomes

  • Recurrence Rate [6 months postoperatively]: The main postoperative primary outcomes measure the recurrence rate

Secondary outcomes

  • Graft stability [1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively]: postoperative Graft stability rated from grade 0 to 4 using a 5 point scale
  • Postoperative inflammation [1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively]: postoperative inflammation rated from grade 0 to 4 using a 5 point scale
  • Postoperative discomfort [1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively]: postoperative discomfort rated from 0 to 10 on the Visual Analogue Scale (VAS)
  • Overall patient satisfaction [1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively]: Overall satisfaction with the procedure 4 weeks post-operatively will recorded as four grades 0= unsatisfied, 1= low satisfaction, 2= moderate satisfaction and 3= highly satisfied, the data were collected as mean scores and recorded. The three groups will compared for overall satisfaction.
  • Complications [1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively]: Complications recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis.

+Eligibility

Sex: All

Inclusion Criteria:

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

Exclusion Criteria:

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

My Notes