Pterygium of Conjunctiva and CorneaNCT06734663
Clinical Outcomes of Sutured Versus Sutureless Conjunctival Autograft in Primary Pterygium Excision
A study testing Clinical outcomes of sutured versus sutureless conjunctival autograft in primary pterygium excision, pterygium excision and conjuctival graft suturing and pterygium excision and conjuctival graft placement by autologous blood in people with Pterygium of Conjunctiva and Cornea and Pterygium of Both Eyes, run by Assiut University at 2 sites in Egypt.
Trial summary
The goal of this study is to find out if a certain technique in pterygium excision surgery ,using no sutures, is better than the technique mostly used ,which uses sutures. Investigators aim to find out whether the no sutures technique provides better efficiency and patient satisfaction than the traditional approach. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pterygium of Conjunctiva and Cornea, Pterygium of Both Eyes, Pterygium
- What is being tested?
- Clinical outcomes of sutured versus sutureless conjunctival autograft in primary pterygium excision, pterygium excision and conjuctival graft suturing and pterygium excision and conjuctival graft placement by autologous blood
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Dec 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged between 18-60 years old.
- Patients diagnosed with primary Pterygium (Grades 1-4)
Who cannot join
- Patients unable to offer viable consent
- Patients with other significant ocular surface diseases, bleeding disorders, or systemic conditions affecting wound healing.)
- Recurrent pterygium
- Combined ocular surgery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
Ophthalmology department Assiut university
Asyut, Asyut Governorate
amal sherif, Resident, 201000247100, amaalsheriff@gmail.com
Ophthalmology department, Assiut University hospital
Asyut
About this study
The goal of this study is to find out if a certain technique in pterygium excision surgery ,using no sutures, is better than the technique mostly used ,which uses sutures.
Investigators aim to find out whether the no sutures technique provides better efficiency and patient satisfaction than the traditional approach. They predict that if this study provides evidence of the advantages of this technique over the one used, surgeons would be encouraged to use it instead. Because not only would the patient benefit, the surgeon also may save operative time and effort used in the technique which uses sutures.
Read the detailed description
This study is a comparative interventional study, in which patients are assigned into two groups comparable in age, gender, and general condition. The first group consists of patients with primary pterygium who will undergo surgery in a traditional approach in which the pterygium is surgically removed and after which a conjuctival graft is placed on the exposed sclera and sutured to the surrounding conjuctiva; in comparison, patients of the second group undergo pterygium excision in a similar matter initially.But the conjuctival graft is placed on the exposed sclera without suturing it to the nearby conjuctiva; instead, the graft remains in place using the patient's autologous blood. Fresh blood is left under the graft, while the surgeon merely compresses the graft for a few minutes. The aim of this study is to reach a conclusion as to which technique is more beneficial, to the patient and surgeon.
Patients included in this study must have primary pterygium, no known hematological condition, and full consent to the study. Surgery time is recorded to compare the effect of avoiding sutures on the surgeon's speed. After that, Patients are followed up in documented certain intervals post-operative, to assess graft displacement, signs of inflammation, signs of bleeding under graft, and patients' overall discomfort and satisfaction.
Finally, the two groups are compared with all factors taken into consideration. The ultimate target is to document evidence of the efficiency of the sutureless technique and endorse its application by Ophthalmologists elsewhere.
- Being tested
- Clinical outcomes of sutured versus sutureless conjunctival autograft in primary pterygium excision, pterygium excision and conjuctival graft suturing, pterygium excision and conjuctival graft placement by autologous blood
- Keywords
- pterygium surgery, sutureless pterygium, autologous blood, serum, pterygium excision using autologous blood in comparison to using sutures, new techniques in pterygium surgery
- Medical subject headings
- Pterygium Of Conjunctiva And Cornea, Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical outcomes of sutured versus sutureless conjunctival autograft in primary pterygium excisionProcedure or surgery
Studies have concluded that pterygium surgical excision is the main treatment for pterygium. Pterygium excision with superior graft is the procedure followed most commonly at present. This is achieved by many methods, with the result differing from one method to another. The most important difference is the incidence of recurrence(4)But Varioustechniques such as Bare Sclera, Rotational Conjunctival Flap, Limbal Conjunctival Autograft, Amniotic Membrane Graft, and Free Conjunctival Autograft are also used for the removal of pterygium(3 ,4)Of the various possible alternative approaches, conjunctival autograft is usually preferred. Diverse methods for grafting with sutures, glue or autologous serum from the recipient bed are in use (5,6). Many adjunctive therapies like mitomycin C, corticosteroids, thiotepa, interferon-alpha- 2b, beta irradiation, 5-FU are being used to decrease the risk of recurrence after surgical removal of pterygium.
pterygium excision and conjuctival graft suturingProcedure or surgery
pterygium is surgically removed, and a conjuctival graft is placed on bare sclera using sutures to surrounding conjuctiva.
pterygium excision and conjuctival graft placement by autologous bloodProcedure or surgery
pterygium is surgically removed and a conjuctival graft is placed on bare sclera on which the patient's blood remains. the graft is left without sutures, adhering only by autologous blood.
| Study group | Role | What they receive |
|---|---|---|
| pterygium excision using sutured technique | Placebo comparator | This represents the main used technique in pterygium surgery that we will compare the less familiar sutureless technique to. pterygium is surgically removed and conjuctival graft is placed using sutures Receives: Procedure: Clinical outcomes of sutured versus sutureless conjunctival autograft in primary pterygium excision; Procedure: pterygium excision and conjuctival graft suturing |
| sutureless technique | Active comparator | this represents the experimented technique in which pterygium excision is done and the graft is placed sutureless. Receives: Procedure: Clinical outcomes of sutured versus sutureless conjunctival autograft in primary pterygium excision; Procedure: pterygium excision and conjuctival graft placement by autologous blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the rate of conjuctival graft displacement in pterygium excision and graft placement without sutures
the most valuable aim in this comparative study is to document if the graft placed sutureless will remain in place.So, in each follow-up, graft is assessed in regards to placement.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start15 Dec 2024 (estimated)
- Primary completion20 Apr 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pterygium of Conjunctiva and CorneaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Sherif Sayed Abdelrehim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734663
- Sponsor's protocol ID
- IRB
- Status last verified
- Dec 2024
- First submitted
- 17 Nov 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Sutured Versus Sutureless Conjunctival Autograft in Primary Pterygium Excision
- ClinicalTrials.gov ID
- NCT06734663
- Acronym / sponsor ID
- IRB
- Keywords
- pterygium surgery, sutureless pterygium, autologous blood, serum, pterygium excision using autologous blood in comparison to using sutures, new techniques in pterygium surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 20 Apr 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 16 Dec 2024 (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 goal of this study is to find out if a certain technique in pterygium excision surgery ,using no sutures, is better than the technique mostly used ,which uses sutures.
Investigators aim to find out whether the no sutures technique provides better efficiency and patient satisfaction than the traditional approach. They predict that if this study provides evidence of the advantages of this technique over the one used, surgeons would be encouraged to use it instead. Because not only would the patient benefit, the surgeon also may save operative time and effort used in the technique which uses sutures.
Detailed description
This study is a comparative interventional study, in which patients are assigned into two groups comparable in age, gender, and general condition. The first group consists of patients with primary pterygium who will undergo surgery in a traditional approach in which the pterygium is surgically removed and after which a conjuctival graft is placed on the exposed sclera and sutured to the surrounding conjuctiva; in comparison, patients of the second group undergo pterygium excision in a similar matter initially.But the conjuctival graft is placed on the exposed sclera without suturing it to the nearby conjuctiva; instead, the graft remains in place using the patient's autologous blood. Fresh blood is left under the graft, while the surgeon merely compresses the graft for a few minutes. The aim of this study is to reach a conclusion as to which technique is more beneficial, to the patient and surgeon.
Patients included in this study must have primary pterygium, no known hematological condition, and full consent to the study. Surgery time is recorded to compare the effect of avoiding sutures on the surgeon's speed. After that, Patients are followed up in documented certain intervals post-operative, to assess graft displacement, signs of inflammation, signs of bleeding under graft, and patients' overall discomfort and satisfaction.
Finally, the two groups are compared with all factors taken into consideration. The ultimate target is to document evidence of the efficiency of the sutureless technique and endorse its application by Ophthalmologists elsewhere.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pterygium excision using sutured technique | Placebo comparator | Procedure: Clinical outcomes of sutured versus sutureless conjunctival autograft in primary pterygium excision, Procedure: pterygium excision and conjuctival graft suturingThis represents the main used technique in pterygium surgery that we will compare the less familiar sutureless technique to. pterygium is surgically removed and conjuctival graft is placed using sutures |
| sutureless technique | Active comparator | Procedure: Clinical outcomes of sutured versus sutureless conjunctival autograft in primary pterygium excision, Procedure: pterygium excision and conjuctival graft placement by autologous bloodthis represents the experimented technique in which pterygium excision is done and the graft is placed sutureless. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults aged between 18-60 years old.
- Patients diagnosed with primary Pterygium (Grades 1-4)
Key exclusion criteria (4 listed)
- Patients unable to offer viable consent
- Patients with other significant ocular surface diseases, bleeding disorders, or systemic conditions affecting wound healing.)
- Recurrent pterygium
- Combined 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 |
|---|---|---|
| Clinical outcomes of sutured versus sutureless conjunctival autograft in primary pterygium excisionStudies have concluded that pterygium surgical excision is the main treatment for pterygium. Pterygium excision with superior graft is the procedure followed most commonly at present. This is achieved by many methods, with the result differing from one method to another. The most important difference is the incidence of recurrence(4)But Varioustechniques such as Bare Sclera, Rotational Conjunctival Flap, Limbal Conjunctival Autograft, Amniotic Membrane Graft, and Free Conjunctival Autograft are also used for the removal of pterygium(3 ,4)Of the various possible alternative approaches, conjunctival autograft is usually preferred. Diverse methods for grafting with sutures, glue or autologous serum from the recipient bed are in use (5,6). Many adjunctive therapies like mitomycin C, corticosteroids, thiotepa, interferon-alpha- 2b, beta irradiation, 5-FU are being used to decrease the risk of recurrence after surgical removal of pterygium. | Procedure or surgery | pterygium excision using sutured technique, sutureless technique |
| pterygium excision and conjuctival graft suturingpterygium is surgically removed, and a conjuctival graft is placed on bare sclera using sutures to surrounding conjuctiva. | Procedure or surgery | pterygium excision using sutured technique |
| pterygium excision and conjuctival graft placement by autologous bloodpterygium is surgically removed and a conjuctival graft is placed on bare sclera on which the patient's blood remains. the graft is left without sutures, adhering only by autologous blood. | Procedure or surgery | sutureless technique |
Primary outcome
to evaluate the rate of conjuctival graft displacement in pterygium excision and graft placement without sutures
Time frame: 3 months
the most valuable aim in this comparative study is to document if the graft placed sutureless will remain in place.So, in each follow-up, graft is assessed in regards to placement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: Yes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical outcomes of sutured versus sutureless conjunctival autograft in primary pterygium excision, pterygium excision and conjuctival graft suturing and pterygium excision and conjuctival graft placement by autologous blood in people with Pterygium of Conjunctiva and Cornea and Pterygium of Both Eyes, run by Assiut University at 2 sites 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 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: opening soon, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amal Resident Doctor (+20 1000247100, amaalsheriff@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the rate of conjuctival graft displacement in pterygium excision and graft placement without sutures (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2024.