The Corneal and Conjunctiva Sensation Before and After Pterygium Surgeries

Pterygium Clinical Trial

Official title:

The Corneal and Conjunctiva Sensation Before and After Pterygium Surgeries

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03314389
• Other study ID #: SHEBA-17-4417-OZ-CTIL
• 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
• 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

Related Conditions & MeSH terms

• Pterygium

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