PterygiumNCT05026307
Corneal Topographic Changes After Pterygium Surgery
A study testing Excision of pterygium in people with Pterygium, run by Sohag University at 1 site in Egypt.
Trial summary
The purpose of the study is to assess the corneal topographic changes after primary pterygium surgery Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pterygium
- What is being tested?
- Excision of pterygium
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2021to Feb 2022
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with primary pterygium
Who cannot join
- patients with recurrent pterygium
- patients with primary pterygium with other ocular pathologies.
Trial locations and contacts
1 site in 1 country.
Gamal A Radwan, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag
Sohag, 82511
Osama R ElSherif, professor
About this study
The purpose of the study is to assess the corneal topographic changes after primary pterygium surgery
Read the detailed description
Prospective interventional comparative study . This study will be conducted on eyes with primary pterygium before and after successful excision in department of ophthalmology, Sohag university hospital to assess the corneal topographic changes using pentacam .
Postoperative evaluation will be scheduled for one month ,three and six months postoperative.
- Conditions
- Pterygium
- Being tested
- Excision of pterygium
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excision of pterygiumProcedure or surgery
Simple surgical excision of pterygium with bare sclera
| Study group | Role | What they receive |
|---|---|---|
| Pterygium | Experimental | Simple surgical excision of pterygium withe bare sclera Receives: Procedure: Excision of pterygium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in corneal topography
Detection of changes in corneal topography using Pentacam
Measured: One month, three and six months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start15 Jun 2021
- Primary completionDec 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PterygiumStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ahmed Abdelraheem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026307
- Sponsor's protocol ID
- Soh-Med-21-06-03
- Status last verified
- Aug 2021
- First submitted
- 22 Aug 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nangia V, Jonas JB, Nair D, Saini N, Nangia P, Panda-Jonas S. Prevalence and associated factors for pterygium in rural agrarian central India. The central India eye and medical study. PLoS One. 2013 Dec 4;8(12):e82439. doi: 10.1371/journal.pone.0082439. eCollection 2013.
PubMed 24324789Moran DJ, Hollows FC. Pterygium and ultraviolet radiation: a positive correlation. Br J Ophthalmol. 1984 May;68(5):343-6. doi: 10.1136/bjo.68.5.343.
PubMed 6712914Di Girolamo N, Chui J, Coroneo MT, Wakefield D. Pathogenesis of pterygia: role of cytokines, growth factors, and matrix metalloproteinases. Prog Retin Eye Res. 2004 Mar;23(2):195-228. doi: 10.1016/j.preteyeres.2004.02.002.
PubMed 15094131Xu Z, Li W, Jiang J, Zhuang X, Chen W, Peng M, Wang J, Lu F, Shen M, Wang Y. Characteristic of entire corneal topography and tomography for the detection of sub-clinical keratoconus with Zernike polynomials using Pentacam. Sci Rep. 2017 Nov 28;7(1):16486. doi: 10.1038/s41598-017-16568-y.
PubMed 29184086
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Topographic Changes After Pterygium Surgery
- ClinicalTrials.gov ID
- NCT05026307
- Acronym / sponsor ID
- Soh-Med-21-06-03
- Conditions
- Pterygium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 30 Aug 2021 (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 the study is to assess the corneal topographic changes after primary pterygium surgery
Detailed description
Prospective interventional comparative study . This study will be conducted on eyes with primary pterygium before and after successful excision in department of ophthalmology, Sohag university hospital to assess the corneal topographic changes using pentacam .
Postoperative evaluation will be scheduled for one month ,three and six months postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pterygium | Experimental | Procedure: Excision of pterygiumSimple surgical excision of pterygium withe bare sclera |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with primary pterygium
Key exclusion criteria (2 listed)
- patients with recurrent pterygium
- patients with primary pterygium with other ocular pathologies.
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 |
|---|---|---|
| Excision of pterygiumSimple surgical excision of pterygium with bare sclera | Procedure or surgery | Pterygium |
Primary outcome
Changes in corneal topography
Time frame: One month, three and six months postoperative
Detection of changes in corneal topography using Pentacam
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Background: PubMed 24324789Nangia V, Jonas JB, Nair D, Saini N, Nangia P, Panda-Jonas S. Prevalence and associated factors for pterygium in rural agrarian central India. The central India eye and medical study. PLoS One. 2013 Dec 4;8(12):e82439. doi: 10.1371/journal.pone.0082439. eCollection 2013.
- Background: PubMed 6712914Moran DJ, Hollows FC. Pterygium and ultraviolet radiation: a positive correlation. Br J Ophthalmol. 1984 May;68(5):343-6. doi: 10.1136/bjo.68.5.343.
- Background: PubMed 15094131Di Girolamo N, Chui J, Coroneo MT, Wakefield D. Pathogenesis of pterygia: role of cytokines, growth factors, and matrix metalloproteinases. Prog Retin Eye Res. 2004 Mar;23(2):195-228. doi: 10.1016/j.preteyeres.2004.02.002.
- Background: PubMed 29184086Xu Z, Li W, Jiang J, Zhuang X, Chen W, Peng M, Wang J, Lu F, Shen M, Wang Y. Characteristic of entire corneal topography and tomography for the detection of sub-clinical keratoconus with Zernike polynomials using Pentacam. Sci Rep. 2017 Nov 28;7(1):16486. doi: 10.1038/s41598-017-16568-y.
- Individual participant dataSharing planned: Undecided
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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.
Gamal A Radwan, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excision of pterygium in people with Pterygium, run by Sohag University at 1 site in Egypt.
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 2 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 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Sara a abdel raheem, resident (01153987387, saraalalem2020@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in corneal topography (time frame: One month, three and six months postoperative). 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 NCT05026307, which also lists 4 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 30 Aug 2021.