Corneal TopographyNCT05812508
Comparison Between Bare Scleral Technique and Conjunctival Auto-graft on Corneal Topography After Pterygium Surgery
An observational study of Corneal Topography, run by Sohag University.
Trial summary
Aim of the work: To study the corneal topographic pattern changes in patients who have pterygium excision by two surgical techniques (bare sclera, conjunctival autograft). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Corneal Topography
- What is being tested?
- corneal topography
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2023to 1 Oct 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pterygium not associated with other pathologies in the eye (suitable for excision) .
Who may be able to join
- Patients with pterygium not associated with other pathologies (suitable for excision).
- Nasal pterygium extended to the cornea.
Who cannot join
- Associated pathologies such as glaucoma, and cataract.
- Corneal opacities or irregularities, scars, dystrophy or ectasia.
- Patients who underwent previous corneal surgery (including refractive surgery)
- Pseudo-pterygium.
Trial locations and contacts
No sites are listed yet.
Alahmady Hamad Elsamman, MD contact
About this study
Official title: A Comparative Study Between Bare Scleral Technique and Conjunctival Autograft on Corneal Topography After Pterygium Surgery
Aim of the work:
To study the corneal topographic pattern changes in patients who have pterygium excision by two surgical techniques (bare sclera, conjunctival autograft).
Read the detailed description
Pterygium is one of the common ocular surface disorders , it's is an elastotic triangular fibro-vascular tissue covered by conjunctival epithelium that spreads over the cornea. Pterygium causes differences in curvature \& power across the cornea .
The prevalence of pterygium varies from 1.1% to 53% globally in different environmental conditions. Risk factors include;UV radiation, geographical latitude near to the equator, outdoor activity , aging, male, and dusty environment.
Pterygium excision is important in patients suffering from blurred vision due to astigmatism . Surgical techniques include ; bare sclera excision, conjunctival autograft, conjunctival transpositional flap, and amniotic membrane grafting. Pterygium excision increases in the mean central corneal curvature \& reduces astigmatism that leads to improvement in visual acuity.
Corneal topography is a gold standard in corneal pathology follow-up. Corneal topography is a computer assisted diagnostic tool that creates a three-dimensional map of the surface curvature of the cornea. Corneal topography produces a detailed, visual description of the shape and power of the cornea.
In this study , corneal topography is used to detect how does corneal curvature change after excision of pterygium .
- Conditions
- Corneal Topography
- Being tested
- corneal topography
- Keywords
- pterygium surgery by bare scleral & autograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corneal topographyDevice
corneal topography before and after pterygium surgery by two techniques bare scleral and conjunctival autograft
| Study group | Role | What they receive |
|---|---|---|
| pterygium surgery with bare scleral technique | corneal topograghy before and after surgery Receives: Device: corneal topography | |
| pterygium surgery with conjunctival autograft technique | corneal topograghy before and after surgery Receives: Device: corneal topography |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of topography finding after pterygium surgery by the bare scleral technique.
To investigate the corneal topographic changes by imaging the corneal topography before and after pterygium excision (by the bare scleral technique); to detect corneal curvature changes.
Measured: baseline
comparison of topography finding after pterygium surgery by the conjunctival auto-graft technique.
To investigate the corneal topographic changes by imaging the corneal topography before and after pterygium excision (by the conjunctival auto-graft technique); to detect corneal curvature changes.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start20 Apr 2023 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corneal TopographyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Mahmoud Ali, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812508
- Sponsor's protocol ID
- Soh-Med-22-10-02
- Status last verified
- Apr 2023
- First submitted
- 4 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yilmaz S, Yuksel T, Maden A. Corneal topographic changes after four types of pterygium surgery. J Refract Surg. 2008 Feb;24(2):160-5. doi: 10.3928/1081597X-20080201-06.
PubMed 18297940
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Bare Scleral Technique and Conjunctival Autograft on Corneal Topography After Pterygium Surgery
- ClinicalTrials.gov ID
- NCT05812508
- Acronym / sponsor ID
- Soh-Med-22-10-02
- Conditions
- Corneal Topography
- Keywords
- pterygium surgery by bare scleral & autograft
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 13 Apr 2023 (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.
Aim of the work:
To study the corneal topographic pattern changes in patients who have pterygium excision by two surgical techniques (bare sclera, conjunctival autograft).
Detailed description
Pterygium is one of the common ocular surface disorders , it's is an elastotic triangular fibro-vascular tissue covered by conjunctival epithelium that spreads over the cornea. Pterygium causes differences in curvature \& power across the cornea .
The prevalence of pterygium varies from 1.1% to 53% globally in different environmental conditions. Risk factors include;UV radiation, geographical latitude near to the equator, outdoor activity , aging, male, and dusty environment.
Pterygium excision is important in patients suffering from blurred vision due to astigmatism . Surgical techniques include ; bare sclera excision, conjunctival autograft, conjunctival transpositional flap, and amniotic membrane grafting. Pterygium excision increases in the mean central corneal curvature \& reduces astigmatism that leads to improvement in visual acuity.
Corneal topography is a gold standard in corneal pathology follow-up. Corneal topography is a computer assisted diagnostic tool that creates a three-dimensional map of the surface curvature of the cornea. Corneal topography produces a detailed, visual description of the shape and power of the cornea.
In this study , corneal topography is used to detect how does corneal curvature change after excision of pterygium .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pterygium surgery with bare scleral technique | – | Device: corneal topographycorneal topograghy before and after surgery |
| pterygium surgery with conjunctival autograft technique | – | Device: corneal topographycorneal topograghy before and after surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pterygium not associated with other pathologies in the eye (suitable for excision) .
Key inclusion criteria (2 listed)
- Patients with pterygium not associated with other pathologies (suitable for excision).
- Nasal pterygium extended to the cornea.
Key exclusion criteria (4 listed)
- Associated pathologies such as glaucoma, and cataract.
- Corneal opacities or irregularities, scars, dystrophy or ectasia.
- Patients who underwent previous corneal surgery (including refractive surgery)
- Pseudo-pterygium.
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 |
|---|---|---|
| corneal topographycorneal topography before and after pterygium surgery by two techniques bare scleral and conjunctival autograft | Device | pterygium surgery with bare scleral technique, pterygium surgery with conjunctival autograft technique |
Primary outcome
comparison of topography finding after pterygium surgery by the bare scleral technique.
Time frame: baseline
To investigate the corneal topographic changes by imaging the corneal topography before and after pterygium excision (by the bare scleral technique); to detect corneal curvature changes.
comparison of topography finding after pterygium surgery by the conjunctival auto-graft technique.
Time frame: baseline
To investigate the corneal topographic changes by imaging the corneal topography before and after pterygium excision (by the conjunctival auto-graft technique); to detect corneal curvature changes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Background: PubMed 18297940Yilmaz S, Yuksel T, Maden A. Corneal topographic changes after four types of pterygium surgery. J Refract Surg. 2008 Feb;24(2):160-5. doi: 10.3928/1081597X-20080201-06.
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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.
Alahmady Hamad Elsamman, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Topography, run by Sohag University.
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 2 inclusion and 4 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 13 Apr 2023. 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 Zeinab Mahmoud Aly, bechlor (01224483318, drzeinabmahmoud32@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of topography finding after pterygium surgery by the bare scleral technique. (time frame: baseline). The study lists 2 primary outcomes in all. 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 NCT05812508, which also lists 1 linked publication.
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 13 Apr 2023.