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CompletedNCT03507283Updated Apr 26, 2018

Vertical Split Conjunctival Autograft in Double-head Pterygia

An observational study in Pterygium of Conjunctiva and Cornea, sponsored by Benha University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-26.

Sponsored by Benha University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
15
Ages
18 Years and older
Sex
All
01

Study summary

15 eyes of 15 patients with primary double-headed pterygia that underwent vertical split conjunctival autograft pterygium surgery were retrospectively reviewed. All patients had primary double-headed pterygia. Recurrence was defined as fibrovascular proliferation over the limbus onto the cornea.

Vertical split conjunctival autograft using fibrin glue is an effective technique with good cosmetic results and low to no recurrence for primary double head pterygia treatment.

Read the detailed description

The pterygium body was dissected from the sclera. Complete excision of the pterygium, subconjunctival Tenon's tissue and surrounding fibrovascular tissues followed.The conjunctival edge was trimmed. The corneal surface was gently scraped with a scalpel. The Same procedure was done on temporal pterygia. A free conjunctival autograft was obtained. The graft was divided vertically into two parts. The nasal part of the graft was cut from limbal attachment including limbal tissue; temporal part was left attached. The nasal part of the graft was moved to the nasal conjunctival defect and attached to the sclera with fibrin sealant (Tisseel; Baxter, Vienna, Austria). The Same procedure was done with the temporal part of the graft. The orientation of graft was ensured before securing it.

02

Conditions studied

  • Pterygium of Conjunctiva and Cornea

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Keywords

  • Pterygium
  • double-headed
  • vertical
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

This study included 15 eyes of 15 patients. The mean age of all patients was 36.92 ± 10.8 years. There were 9 males (60%) and 6 females (40%).

Inclusion criteria

  • Primary double-headed pterygia

Exclusion criteria

Exclusion Criteria:

  • NONE
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
15 participants (actual)
Patient registry
No

Interventions

  • ProcedureDouble head pterygia excision and repair

    Complete excision of the pterygia was done. A free conjunctival autograft was obtained. The graft was divided vertically into two parts then secured into conjunctival defects.

05

What researchers measure

Primary outcomes

  1. The recurrence rate

    fibrovascular tissue invading the cornea and expressed as a percentage

    Time frame: 1 year

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Elhamaky TR, Elbarky AM. Outcomes of Vertical Split Conjunctival Autograft Using Fibrin Glue in Treatment of Primary Double-Headed Pterygia. J Ophthalmol. 2018 Dec 20;2018:9341846. doi: 10.1155/2018/9341846. eCollection 2018. PubMed 30671262 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03507283
Lead sponsor
Benha University
Responsible party
Tarek Roshdy mohamed Mahgoub ELhamaky (lecturer of ophthalmology, Benha University) — Principal investigator
First posted
Apr 25, 2018
Start date
Apr 2011
Primary completion
Apr 2016
Completion
Aug 2016
Last update
Apr 26, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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