The Corneal and Conjunctiva Sensation Before and After Pterygium Surgeries

April 20, 2018 updated by: Dr. Ofira Zloto, Sheba Medical Center
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cochet bonnet esthesiometer
To examine sensation
Device: Cochet bonnet esthesiometer
Cochet bonnet esthesiometer- To examine sensation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To sensation before and after pterygium surgeries as measured by Cochet bonnet esthesiometer
Time Frame: 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
Before surgery compare to one week+ one month+three months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2018

Primary Completion (ANTICIPATED)

January 1, 2019

Study Completion (ANTICIPATED)

October 1, 2019

Study Registration Dates

First Submitted

October 9, 2017

First Submitted That Met QC Criteria

October 17, 2017

First Posted (ACTUAL)

October 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 23, 2018

Last Update Submitted That Met QC Criteria

April 20, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-17-4417-OZ-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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