The Corneal and Conjunctiva Sensation Before and After Pterygium Surgeries

Sponsor

Sheba Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT03314389

Collaborator

(none)

100

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pterygium	Device: Cochet bonnet esthesiometer	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

The Corneal and Conjunctiva Sensation Before and After Pterygium Surgeries

Anticipated Study Start Date :

May 1, 2018

Anticipated Primary Completion Date :

Jan 1, 2019

Anticipated Study Completion Date :

Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cochet bonnet esthesiometer To examine sensation	Device: Cochet bonnet esthesiometer Cochet bonnet esthesiometer- To examine sensation

Arm

Intervention/Treatment

Experimental: Cochet bonnet esthesiometer

To examine sensation

Device: Cochet bonnet esthesiometer

Cochet bonnet esthesiometer- To examine sensation

Outcome Measures

Primary Outcome Measures

To sensation before and after pterygium surgeries as measured by Cochet bonnet esthesiometer [Before surgery compare to one week+ one month+three months after surgery]
The change in sensation in the cornea and conjunctiva after pterygium surgery as measured by Cochet bonnet esthesiometer

Secondary Outcome Measures

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]
Dry eye will be measured by Tear break up time
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]
Dry eye will be measured by Schrimer test
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]
Dry eye will be measured by lissamine green test
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]
Visual acuity will be measured by Snellen chart
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]
Refraction will be measured by autorefractometer
To examine the change in anterior chamber that may predicate the change in sensation after pterygium surgery: [Before surgery compare to one week+ one month+three months after surgery]
Anterior chamber slit lamp examination
To examine the change in imaging of anterior segment that may predicate the change in sensation after pterygium surgery: [Before surgery compare to one week+ one month+three months after surgery]
Anterior Chamber Optical coherence tomography( AC-OCT)
To examine the Recurrence of pterygium [one week+ one month+three months after surgery]
Recurrence of pterygium as examined in slit lamp examination

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients that suppose to undergo pterigyum surgery

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Ofira Zloto, Principal Investigator, Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT03314389

Other Study ID Numbers:

SHEBA-17-4417-OZ-CTIL

First Posted:

Oct 19, 2017

Last Update Posted:

Apr 23, 2018

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr. Ofira Zloto, Principal Investigator, Sheba Medical Center

Cochet bonnet esthesiometer

Additional relevant MeSH terms:

Pterygium

Study Results

No Results Posted as of Apr 23, 2018