PterygiumNCT03301974
A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery
A study testing conjunctival autograft with fibrin glue, sutured conjunctival autograft and sutureless and glue-free conjunctival autograft in people with Pterygium, run by Assiut University.
Trial summary
Pterygium is a fibrovascular wing shaped encroachment of conjunctival fold on to the cornea with elastotic degeneration of a subconjunctival tissue, The standard treatment for pterygium is surgical excision, but the recurrence rate after surgery can be as high as 24%-89%, which compromises outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pterygium
- What is being tested?
- conjunctival autograft with fibrin glue, sutured conjunctival autograft and sutureless and glue-free conjunctival autograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 24 Feb 2019to Jan 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients complaining of primary Progressive nasal pterygium.
- Patients with pterygium threatening the visual axis.
Who cannot join
- Double head pterygium.
- Pseudopterygium
- Recurrent pterygium
- Patients with history of any bleeding abnormalities
- Patients with ocular surface diseases eg- blepharitis, Sjogren syndrome and dry eye.
About this study
Pterygium is a fibrovascular wing shaped encroachment of conjunctival fold on to the cornea with elastotic degeneration of a subconjunctival tissue, The standard treatment for pterygium is surgical excision, but the recurrence rate after surgery can be as high as 24%-89%, which compromises outcomes. Based on the simple excision of pterygium, multiple strategies and techniques have been developed to reduce the high rate of pterygium recurrence. The investigators aim was to compare the safety, efficacy, overall patient satisfaction and recurrence rate of suturing, fibrin gluing and sutureless glue-free technique for attaching conjunctival autograft in primary pterygium surgery.
Read the detailed description
Design: Prospective randomized comparative interventional clinical study Setting: Assiut university hospital \& El-Mabarah hospital for health insurance Methods: The study included 60 eyes of 60 consecutive patients of primary nasal pterygium were enrolled in the study. Simple excision under local anesthesia was performed then closure of the bare sclera by conjunctival autograft with fibrin glue in 20 eyes of 20 patients (group 1), versus sutured free conjunctival autograft in 20 eyes of 20 patients (group 2) ), versus sutureless and glue-free conjunctival autograft in 20 eyes of 20 patients (group 3).
- Conditions
- Pterygium
- Being tested
- conjunctival autograft with fibrin glue, sutured conjunctival autograft, sutureless and glue-free conjunctival autograft
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conjunctival autograft with fibrin glueProcedure or surgery
Simple pterygium excision under local anesthesia performed then closure of the bare sclera by fibrin glued conjunctival autograft in 20 eyes of 20 patients (group 1).
sutured conjunctival autograftProcedure or surgery
Simple pterygium excision under local anesthesia performed then closure of the bare sclera by sutured conjunctival autograft in 20 eyes of 20 patients (group 2).
sutureless and glue-free conjunctival autograftProcedure or surgery
Simple pterygium excision under local anesthesia performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 20 eyes of 20 patients (group 3)
| Study group | Role | What they receive |
|---|---|---|
| conjunctival autograft with fibrin glue | Experimental | Conjunctival autograft with fibrin glue done for patients of group 1 after pterygium excision Receives: Procedure: conjunctival autograft with fibrin glue |
| sutured conjunctival autograft | Experimental | Sutured conjunctival autograft done for patients of group 2 after pterygium excision Receives: Procedure: sutured conjunctival autograft |
| sutureless and glue-free conjunctival autograft | Experimental | Sutureless, glue-free conjunctival autograft done for patients of group 3 after pterygium excision Receives: Procedure: sutureless and glue-free conjunctival autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Rate
The main postoperative primary outcomes measure the recurrence rate
Measured: 6 months postoperatively
Secondary outcomes (5)
Graft stability
postoperative Graft stability rated from grade 0 to 4 using a 5 point scale
Measured: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
Postoperative inflammation
postoperative inflammation rated from grade 0 to 4 using a 5 point scale
Measured: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
Postoperative discomfort
postoperative discomfort rated from 0 to 10 on the Visual Analogue Scale (VAS)
Measured: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
Overall patient satisfaction
Overall satisfaction with the procedure 4 weeks post-operatively will recorded as four grades 0= unsatisfied, 1= low satisfaction, 2= moderate satisfaction and 3= highly satisfied, the data were collected as mean scores and recorded. The three groups will compared for overall satisfaction.
Measured: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
Complications
Complications recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis.
Measured: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start24 Feb 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PterygiumStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fathy Ahmed Oraby, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301974
- Sponsor's protocol ID
- 17200138
- Status last verified
- Jan 2019
- First submitted
- 27 Sep 2017
- Last updated
- 9 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery
- ClinicalTrials.gov ID
- NCT03301974
- Acronym / sponsor ID
- 17200138
- Conditions
- Pterygium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 24 Feb 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 4 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.
Pterygium is a fibrovascular wing shaped encroachment of conjunctival fold on to the cornea with elastotic degeneration of a subconjunctival tissue, The standard treatment for pterygium is surgical excision, but the recurrence rate after surgery can be as high as 24%-89%, which compromises outcomes. Based on the simple excision of pterygium, multiple strategies and techniques have been developed to reduce the high rate of pterygium recurrence. The investigators aim was to compare the safety, efficacy, overall patient satisfaction and recurrence rate of suturing, fibrin gluing and sutureless glue-free technique for attaching conjunctival autograft in primary pterygium surgery.
Detailed description
Design: Prospective randomized comparative interventional clinical study Setting: Assiut university hospital \& El-Mabarah hospital for health insurance Methods: The study included 60 eyes of 60 consecutive patients of primary nasal pterygium were enrolled in the study. Simple excision under local anesthesia was performed then closure of the bare sclera by conjunctival autograft with fibrin glue in 20 eyes of 20 patients (group 1), versus sutured free conjunctival autograft in 20 eyes of 20 patients (group 2) ), versus sutureless and glue-free conjunctival autograft in 20 eyes of 20 patients (group 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conjunctival autograft with fibrin glue | Experimental | Procedure: conjunctival autograft with fibrin glueConjunctival autograft with fibrin glue done for patients of group 1 after pterygium excision |
| sutured conjunctival autograft | Experimental | Procedure: sutured conjunctival autograftSutured conjunctival autograft done for patients of group 2 after pterygium excision |
| sutureless and glue-free conjunctival autograft | Experimental | Procedure: sutureless and glue-free conjunctival autograftSutureless, glue-free conjunctival autograft done for patients of group 3 after pterygium excision |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients complaining of primary Progressive nasal pterygium.
- Patients with pterygium threatening the visual axis.
Key exclusion criteria (5 listed)
- Double head pterygium.
- Pseudopterygium
- Recurrent pterygium
- Patients with history of any bleeding abnormalities
- Patients with ocular surface diseases eg- blepharitis, Sjogren syndrome and dry eye.
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 |
|---|---|---|
| conjunctival autograft with fibrin glueSimple pterygium excision under local anesthesia performed then closure of the bare sclera by fibrin glued conjunctival autograft in 20 eyes of 20 patients (group 1). | Procedure or surgery | conjunctival autograft with fibrin glue |
| sutured conjunctival autograftSimple pterygium excision under local anesthesia performed then closure of the bare sclera by sutured conjunctival autograft in 20 eyes of 20 patients (group 2). | Procedure or surgery | sutured conjunctival autograft |
| sutureless and glue-free conjunctival autograftSimple pterygium excision under local anesthesia performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 20 eyes of 20 patients (group 3) | Procedure or surgery | sutureless and glue-free conjunctival autograft |
Primary outcome
Recurrence Rate
Time frame: 6 months postoperatively
The main postoperative primary outcomes measure the recurrence rate
5 secondary outcomes
Graft stability
Time frame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
Postoperative inflammation
Time frame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
Postoperative discomfort
Time frame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
Overall patient satisfaction
Time frame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
Complications
Time frame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
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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 conjunctival autograft with fibrin glue, sutured conjunctival autograft and sutureless and glue-free conjunctival autograft in people with Pterygium, run by Assiut 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 5 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 9 Jan 2019. 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?
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: 6 months postoperatively). 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 9 Jan 2019.