Pterygium of Conjunctiva and CorneaNCT03363282
Recurrence Rate of Mini-SLET vs. Limbal-Conjunctival Autograft in Primary Pterygium Excision
A study testing Pterygium Excision in people with Pterygium of Conjunctiva and Cornea, run by Instituto de Oftalmología Fundación Conde de Valenciana.
Trial summary
To study the efficacy and safety of amniotic membrane transplantation as an adjunctive therapy after surgical excision of primary pterygium and compare the clinical outcomes with conjunctival autograft Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pterygium of Conjunctiva and Cornea
- What is being tested?
- Pterygium Excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- 17 Sep 2015to 28 Nov 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with primary nasal pterygium > 2mm
Who cannot join
- Pregnant
- Previous ocular surgery
About this study
Official title: Recurrence Rate of Mini-SLET (Simple Limbal Epithelial Transplantation) vs. Limbal-Conjunctival Autograft in Primary Pterygium Excision
To study the efficacy and safety of amniotic membrane transplantation as an adjunctive therapy after surgical excision of primary pterygium and compare the clinical outcomes with conjunctival autograft
Read the detailed description
Prospective Randomized Blind Clinical Trial
Sixty-four eyes of 64 patients with primary nasal pterygium have been operated by two surgeons (E. G-H, A. N-C). All patients are randomized to undergo Mini-SLET or limbal-conjunctival autograft transplantation as an adjuvant therapy after pterygium excision.
Four eyes were treated with Mini-SLET(group 1), and 26 eyes have been operated with conjunctival autograft (group 2). Patients will be followed up at 1 day, 1 week, 1, 3, 6, 9 and 12 months postoperation. The main outcome measurement was a recurrence rate after surgery.
- Conditions
- Pterygium of Conjunctiva and Cornea
- Being tested
- Pterygium Excision
- Keywords
- Crosslinking
- Medical subject headings
- Pterygium Of Conjunctiva And Cornea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pterygium ExcisionProcedure or surgery
Also called Limbal-Conjunctival Autograft, Mini-SLET
Pterygium excision is the first step for repair
| Study group | Role | What they receive |
|---|---|---|
| Mini-SLET | Experimental | Simple Limbal Epithelial Transplantation Receives: Procedure: Pterygium Excision |
| Limbal-Conjunctival Autograft | Experimental | Patients treated with limbal-conjunctival autograft Receives: Procedure: Pterygium Excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Regrowth of pterygium
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start17 Sep 2015
- Primary completion17 Nov 2016
- Study completion28 Nov 2017
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 Pterygium of Conjunctiva and CorneaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363282
- Sponsor's protocol ID
- CI-021-2015
- Status last verified
- Mar 2018
- First submitted
- 30 Nov 2017
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will be analyzed by a single researcher
Publications
Tseng SC. Concept and application of limbal stem cells. Eye (Lond). 1989;3 ( Pt 2):141-57. doi: 10.1038/eye.1989.22.
PubMed 2695347Tananuvat N, Martin T. The results of amniotic membrane transplantation for primary pterygium compared with conjunctival autograft. Cornea. 2004 Jul;23(5):458-63. doi: 10.1097/01.ico.0000116522.57227.97.
PubMed 15220729Kucukerdonmez C, Akova YA, Altinors DD. Comparison of conjunctival autograft with amniotic membrane transplantation for pterygium surgery: surgical and cosmetic outcome. Cornea. 2007 May;26(4):407-13. doi: 10.1097/ICO.0b013e318033b3d4.
PubMed 17457187Oliva-Bienzobas V, Nava-Castaneda A, Jimenez-Corona A, Kahuam-Lopez N, Ramirez-Miranda A, Navas A, Graue-Hernandez EO. Comparison of mini-simple limbal epithelial transplantation and conjunctival-limbal autograft for the treatment of primary pterygium: a randomised controlled trial. Br J Ophthalmol. 2023 Nov 22;107(12):1776-1781. doi: 10.1136/bjo-2021-320707.
PubMed 37739769
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrence Rate of Mini-SLET (Simple Limbal Epithelial Transplantation) vs. Limbal-Conjunctival Autograft in Primary Pterygium Excision
- ClinicalTrials.gov ID
- NCT03363282
- Acronym / sponsor ID
- CI-021-2015
- Conditions
- Pterygium of Conjunctiva and Cornea
- Keywords
- Crosslinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- 17 Sep 2015 (actual)
- Primary completion
- 17 Nov 2016 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 6 Dec 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.
To study the efficacy and safety of amniotic membrane transplantation as an adjunctive therapy after surgical excision of primary pterygium and compare the clinical outcomes with conjunctival autograft
Detailed description
Prospective Randomized Blind Clinical Trial
Sixty-four eyes of 64 patients with primary nasal pterygium have been operated by two surgeons (E. G-H, A. N-C). All patients are randomized to undergo Mini-SLET or limbal-conjunctival autograft transplantation as an adjuvant therapy after pterygium excision.
Four eyes were treated with Mini-SLET(group 1), and 26 eyes have been operated with conjunctival autograft (group 2). Patients will be followed up at 1 day, 1 week, 1, 3, 6, 9 and 12 months postoperation. The main outcome measurement was a recurrence rate after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini-SLET | Experimental | Procedure: Pterygium ExcisionSimple Limbal Epithelial Transplantation |
| Limbal-Conjunctival Autograft | Experimental | Procedure: Pterygium ExcisionPatients treated with limbal-conjunctival autograft |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with primary nasal pterygium > 2mm
Key exclusion criteria (2 listed)
- Pregnant
- Previous ocular surgery
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 |
|---|---|---|
| Pterygium ExcisionAlso: Limbal-Conjunctival Autograft, Mini-SLETPterygium excision is the first step for repair | Procedure or surgery | Limbal-Conjunctival Autograft, Mini-SLET |
Primary outcome
Recurrence rate
Time frame: one day
Regrowth of pterygium
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Results publication: PubMed 2695347Tseng SC. Concept and application of limbal stem cells. Eye (Lond). 1989;3 ( Pt 2):141-57. doi: 10.1038/eye.1989.22.
- Results publication: PubMed 15220729Tananuvat N, Martin T. The results of amniotic membrane transplantation for primary pterygium compared with conjunctival autograft. Cornea. 2004 Jul;23(5):458-63. doi: 10.1097/01.ico.0000116522.57227.97.
- Results publication: PubMed 17457187Kucukerdonmez C, Akova YA, Altinors DD. Comparison of conjunctival autograft with amniotic membrane transplantation for pterygium surgery: surgical and cosmetic outcome. Cornea. 2007 May;26(4):407-13. doi: 10.1097/ICO.0b013e318033b3d4.
- Derived from this study: PubMed 37739769Oliva-Bienzobas V, Nava-Castaneda A, Jimenez-Corona A, Kahuam-Lopez N, Ramirez-Miranda A, Navas A, Graue-Hernandez EO. Comparison of mini-simple limbal epithelial transplantation and conjunctival-limbal autograft for the treatment of primary pterygium: a randomised controlled trial. Br J Ophthalmol. 2023 Nov 22;107(12):1776-1781. doi: 10.1136/bjo-2021-320707.
- Individual participant dataSharing planned: No. Patient data will be analyzed by a single researcher
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pterygium Excision in people with Pterygium of Conjunctiva and Cornea, run by Instituto de Oftalmología Fundación Conde de Valenciana.
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: finished, as of the sponsor's last update on 9 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: one day). 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 NCT03363282, 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 9 Mar 2018.