PterygiumNCT03314389
The Corneal and Conjunctiva Sensation Before and After Pterygium Surgeries
A study testing Cochet bonnet esthesiometer in people with Pterygium, run by Sheba Medical Center.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pterygium
- What is being tested?
- Cochet bonnet esthesiometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that suppose to undergo pterigyum surgery
Who cannot join
- Patients with anterior segment diseases Patients that underwent anterior segment surgeries Patients with 7th nerve palsy
Trial locations and contacts
No sites are listed yet.
About this study
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
- Conditions
- Pterygium
- Being tested
- Cochet bonnet esthesiometer
- Keywords
- Cochet bonnet esthesiometer
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochet bonnet esthesiometerDevice
Cochet bonnet esthesiometer- To examine sensation
| Study group | Role | What they receive |
|---|---|---|
| Cochet bonnet esthesiometer | Experimental | To examine sensation Receives: Device: Cochet bonnet esthesiometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before surgery compare to one week+ one month+three months after surgery
Secondary outcomes (8)
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
Measured: 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
Dry eye will be measured by Schrimer test
Measured: 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
Dry eye will be measured by lissamine green test
Measured: 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
Visual acuity will be measured by Snellen chart
Measured: 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:
Refraction will be measured by autorefractometer
Measured: 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:
Anterior chamber slit lamp examination
Measured: 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:
Anterior Chamber Optical coherence tomography( AC-OCT)
Measured: Before surgery compare to one week+ one month+three months after surgery
To examine the Recurrence of pterygium
Recurrence of pterygium as examined in slit lamp examination
Measured: one week+ one month+three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start1 May 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PterygiumStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Ofira Zloto, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314389
- Sponsor's protocol ID
- SHEBA-17-4417-OZ-CTIL
- Status last verified
- Apr 2018
- First submitted
- 9 Oct 2017
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 22081668Julio 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 27362880Pujol 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Corneal and Conjunctiva Sensation Before and After Pterygium Surgeries
- ClinicalTrials.gov ID
- NCT03314389
- Acronym / sponsor ID
- SHEBA-17-4417-OZ-CTIL
- Conditions
- Pterygium
- Keywords
- Cochet bonnet esthesiometer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochet bonnet esthesiometer | Experimental | Device: Cochet bonnet esthesiometerTo examine sensation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that suppose to undergo pterigyum surgery
Key exclusion criteria (1 listed)
- Patients with anterior segment diseases Patients that underwent anterior segment surgeries Patients with 7th nerve palsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochet bonnet esthesiometerCochet bonnet esthesiometer- To examine sensation | Device | Cochet bonnet esthesiometer |
Primary outcome
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
8 secondary outcomes
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
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
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
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
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
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
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
To examine the Recurrence of pterygium
Time frame: one week+ one month+three months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Results publication: PubMed 22081668Sakarya 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.
- Results publication: PubMed 27362880Julio 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.
- Results publication: PubMed 25833130Pujol 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Cochet bonnet esthesiometer in people with Pterygium, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ofra Zloto, MD (972-54-6516220, ozloto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03314389, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.