ClinicalTrials.gg
Status unknownNCT03314389Updated Apr 23, 2018

The Corneal and Conjunctiva Sensation Before and After Pterygium Surgeries

An interventional study of Cochet bonnet esthesiometer in Pterygium, sponsored by Sheba Medical Center. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-23.

Sponsored by Sheba Medical Center · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Pterygium

Browse trials for

Keywords

  • Cochet bonnet esthesiometer
03

In context

Pterygium

109 studies on the registry are indexed under Pterygium; 9 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 93 interventional studies indexed under Pterygium.

Browse Pterygium studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 678 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients that suppose to undergo pterigyum surgery

Exclusion criteria

Exclusion Criteria:

  • Patients with anterior segment diseases Patients that underwent anterior segment surgeries Patients with 7th nerve palsy
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Cochet bonnet esthesiometer

    To examine sensation

    Device: Cochet bonnet esthesiometer

Interventions

  • DeviceCochet bonnet esthesiometer

    Cochet bonnet esthesiometer- To examine sensation

06

What researchers measure

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

    Time frame: Before surgery compare to one week+ one month+three months after surgery

Secondary outcomes

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

    Dry eye will be measured by Tear break up time

    Time frame: Before surgery compare to one week+ one month+three months after surgery

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

    Dry eye will be measured by Schrimer test

    Time frame: Before surgery compare to one week+ one month+three months after surgery

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

    Dry eye will be measured by lissamine green test

    Time frame: Before surgery compare to one week+ one month+three months after surgery

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

    Visual acuity will be measured by Snellen chart

    Time frame: Before surgery compare to one week+ one month+three months after surgery

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

    Refraction will be measured by autorefractometer

    Time frame: Before surgery compare to one week+ one month+three months after surgery

  6. To examine the change in anterior chamber that may predicate the change in sensation after pterygium surgery:

    Anterior chamber slit lamp examination

    Time frame: Before surgery compare to one week+ one month+three months after surgery

  7. To examine the change in imaging of anterior segment that may predicate the change in sensation after pterygium surgery:

    Anterior Chamber Optical coherence tomography( AC-OCT)

    Time frame: Before surgery compare to one week+ one month+three months after surgery

  8. To examine the Recurrence of pterygium

    Recurrence of pterygium as examined in slit lamp examination

    Time frame: one week+ one month+three months after surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 22081668 ↗
  • 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. PubMed 27362880 ↗
  • 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. PubMed 25833130 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03314389
Responsible party
Dr. Ofira Zloto (Principal Investigator, Sheba Medical Center) — Principal investigator
First posted
Oct 19, 2017
Start date
May 1, 2018 (estimated)
Primary completion
Jan 1, 2019 (estimated)
Completion
Oct 1, 2019 (estimated)
Last update
Apr 23, 2018

Study contacts

Ofra Zloto, MD
Contact
ozloto@gmail.com
972-54-6516220

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Apr 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.

Start the discussion