NCT03314389

Brief Summary

The purpose of this current study is to examine the sensation of the corneal and conjunctiva sensation before and after pterygium surgeries by Cochet bonnet esthesiometer and to examine epidemiological, clinical and imaging factors the influence the sensation

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Status
unknown

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

October 9, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

April 23, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

October 9, 2017

Last Update Submit

April 20, 2018

Conditions

Keywords

Cochet bonnet esthesiometer

Outcome Measures

Primary Outcomes (1)

  • To sensation before and after pterygium surgeries as measured by Cochet bonnet esthesiometer

    The change in sensation in the cornea and conjunctiva after pterygium surgery as measured by Cochet bonnet esthesiometer

    Before surgery compare to one week+ one month+three months after surgery

Secondary Outcomes (8)

  • To examine the change in dry eye syndrome that may predicate the change in sensation after pterygium surgery

    Before surgery compare to one week+ one month+three months after surgery

  • To examine the change in dry eye syndrome that may predicate the change in sensation after pterygium surgery

    Before surgery compare to one week+ one month+three months after surgery

  • To examine the change in dry eye syndrome that may predicate the change in sensation after pterygium surgery

    Before surgery compare to one week+ one month+three months after surgery

  • To examine the change in visual acuity that may predicate the change in sensation after pterygium surgery

    Before surgery compare to one week+ one month+three months after surgery

  • To examine the change in refraction that may predicate the change in sensation after pterygium surgery:

    Before surgery compare to one week+ one month+three months after surgery

  • +3 more secondary outcomes

Study Arms (1)

Cochet bonnet esthesiometer

EXPERIMENTAL

To examine sensation

Device: Cochet bonnet esthesiometer

Interventions

Cochet bonnet esthesiometer- To examine sensation

Cochet bonnet esthesiometer

Eligibility Criteria

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

You may qualify if:

  • Patients that suppose to undergo pterigyum surgery

You may not qualify if:

  • Patients with anterior segment diseases Patients that underwent anterior segment surgeries Patients with 7th nerve palsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Sakarya Y, Sakarya R, Kara S. Reversal of sensation of conjunctival autograft after pterygium surgery. Eur J Ophthalmol. 2012;22 Suppl 7:S11-6. doi: 10.5301/ejo.5000082.

  • Julio G, Campos P, Pujol P, Munguia A, Mas-Aixala E. Determining Factors for Fast Corneal Sensitivity Recovery After Pterygium Excision. Cornea. 2016 Dec;35(12):1594-1599. doi: 10.1097/ICO.0000000000000932.

  • Pujol P, Julio G, Barbany M, Asaad M. Healing indicators after pterygium excision by optical coherence tomography. Ophthalmic Physiol Opt. 2015 May;35(3):308-14. doi: 10.1111/opo.12206. Epub 2015 Mar 31.

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Central Study Contacts

Ofra Zloto, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2017

First Posted

October 19, 2017

Study Start

May 1, 2018

Primary Completion

January 1, 2019

Study Completion

October 1, 2019

Last Updated

April 23, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share