NCT01158014

Brief Summary

The use of Fibrin glue to place conjunctival graft will be as effective as suturing the graft, but will require much less operative time and will be better tolerated by the patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2010

Completed
3.5 years until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

2.3 years

First QC Date

July 4, 2010

Last Update Submit

August 7, 2017

Conditions

Conjunctival Autograft

Keywords

pterygiumconjunctival graftrecurrenceprimary pterygium

Outcome Measures

Primary Outcomes (1)

  • Pterygium recurrence

    Recurrence normally occurs 1-6 months after surgery. Success is achieved if ptergium does not recur after one year.

    one year

Secondary Outcomes (1)

  • operation time

    one year

Study Arms (2)

Fibrin Glue, surgery

EXPERIMENTAL

Conjunctival autograft will be glued using fibrin glue to pterygia bed after removal

Procedure: Fibrin Glue, Quixil

Control

ACTIVE COMPARATOR

Conjunctival autograft will be sutured using 10/0 vicryl sutures to pterygia bed after removal

Procedure: Suture

Interventions

Fibrin Glue, QuixilPROCEDURE

quixil 0.1 ml

Fibrin Glue, surgery
SuturePROCEDURE

vicryl 10/0

Control

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary pterygium
  • healthy subject
  • ability to attend follow-up visits

You may not qualify if:

  • recurrent pterygium
  • underwent previous surgery / intervention to treat pterygium
  • ocular surface disease 0 minor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba_Medical_Center

Ramat Gan, 52621, Israel

Location

Related Publications (3)

  • Ratnalingam V, Eu AL, Ng GL, Taharin R, John E. Fibrin adhesive is better than sutures in pterygium surgery. Cornea. 2010 May;29(5):485-9. doi: 10.1097/ICO.0b013e3181c29696.

    PMID: 20308876RESULT

  • Por YM, Tan DT. Assessment of fibrin glue in pterygium surgery. Cornea. 2010 Jan;29(1):1-4. doi: 10.1097/ICO.0b013e3181a38fda.

    PMID: 19907303RESULT

  • Hall RC, Logan AJ, Wells AP. Comparison of fibrin glue with sutures for pterygium excision surgery with conjunctival autografts. Clin Exp Ophthalmol. 2009 Aug;37(6):584-9. doi: 10.1111/j.1442-9071.2009.02105.x.

    PMID: 19702708RESULT

MeSH Terms

Conditions

PterygiumRecurrence

Interventions

Fibrin Tissue AdhesiveSutures

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSurgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

July 4, 2010

First Posted

July 8, 2010

Study Start

January 1, 2014

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations

IL(1)