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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03314389
Other study ID # SHEBA-17-4417-OZ-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 9, 2017
Last updated April 20, 2018
Start date May 1, 2018
Est. completion date October 1, 2019

Study information

Verified date April 2018
Source Sheba Medical Center
Contact Ofra Zloto, MD
Phone 972-54-6516220
Email ozloto@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date October 1, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Cochet bonnet esthesiometer
Cochet bonnet esthesiometer- To examine sensation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 Before surgery compare to one week+ one month+three months after surgery
Secondary 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 Before surgery compare to one week+ one month+three months after surgery
Secondary 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 Before surgery compare to one week+ one month+three months after surgery
Secondary 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 Before surgery compare to one week+ one month+three months after surgery
Secondary To examine the change in refraction that may predicate the change in sensation after pterygium surgery: Refraction will be measured by autorefractometer Before surgery compare to one week+ one month+three months after surgery
Secondary To examine the change in anterior chamber that may predicate the change in sensation after pterygium surgery: Anterior chamber slit lamp examination Before surgery compare to one week+ one month+three months after surgery
Secondary 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) Before surgery compare to one week+ one month+three months after surgery
Secondary To examine the Recurrence of pterygium Recurrence of pterygium as examined in slit lamp examination one week+ one month+three months after surgery
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