CClinicalTrials.gg
Sign In
CompletedNCT03363282Updated Mar 9, 2018

Recurrence Rate of Mini-SLET vs. Limbal-Conjunctival Autograft in Primary Pterygium Excision

An interventional study of Pterygium Excision in Pterygium of Conjunctiva and Cornea, sponsored by Instituto de Oftalmología Fundación Conde de Valenciana. Completed. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-09.

Sponsored by Instituto de Oftalmología Fundación Conde de Valenciana · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

To study the efficacy and safety of amniotic membrane transplantation as an adjunctive therapy after surgical excision of primary pterygium and compare the clinical outcomes with conjunctival autograft

Read the detailed description

Prospective Randomized Blind Clinical Trial

Sixty-four eyes of 64 patients with primary nasal pterygium have been operated by two surgeons (E. G-H, A. N-C). All patients are randomized to undergo Mini-SLET or limbal-conjunctival autograft transplantation as an adjuvant therapy after pterygium excision.

Four eyes were treated with Mini-SLET(group 1), and 26 eyes have been operated with conjunctival autograft (group 2). Patients will be followed up at 1 day, 1 week, 1, 3, 6, 9 and 12 months postoperation. The main outcome measurement was a recurrence rate after surgery.

02

Conditions studied

  • Pterygium of Conjunctiva and Cornea

Keywords

  • Crosslinking
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients with primary nasal pterygium > 2mm

Exclusion criteria

Exclusion Criteria:

  • Pregnant
  • Previous ocular surgery
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    Mini-SLET

    Simple Limbal Epithelial Transplantation

    Procedure: Pterygium Excision

  • Experimental
    Limbal-Conjunctival Autograft

    Patients treated with limbal-conjunctival autograft

    Procedure: Pterygium Excision

Interventions

  • ProcedurePterygium Excision

    Pterygium excision is the first step for repair

    Also known as: Limbal-Conjunctival Autograft, Mini-SLET

05

What researchers measure

Primary outcomes

  1. Recurrence rate

    Regrowth of pterygium

    Time frame: one day

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Tseng SC. Concept and application of limbal stem cells. Eye (Lond). 1989;3 ( Pt 2):141-57. doi: 10.1038/eye.1989.22. PubMed 2695347 ↗
  • Tananuvat N, Martin T. The results of amniotic membrane transplantation for primary pterygium compared with conjunctival autograft. Cornea. 2004 Jul;23(5):458-63. doi: 10.1097/01.ico.0000116522.57227.97. PubMed 15220729 ↗
  • Kucukerdonmez C, Akova YA, Altinors DD. Comparison of conjunctival autograft with amniotic membrane transplantation for pterygium surgery: surgical and cosmetic outcome. Cornea. 2007 May;26(4):407-13. doi: 10.1097/ICO.0b013e318033b3d4. PubMed 17457187 ↗

Individual participant data

Plan to share: No — Patient data will be analyzed by a single researcher

08

Registry details

Key details

Study ID
NCT03363282
Lead sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
Responsible party
Sponsor
First posted
Dec 6, 2017
Start date
Sep 17, 2015
Primary completion
Nov 17, 2016
Completion
Nov 28, 2017
Last update
Mar 9, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pterygium→

Other studies from this sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Start the discussion