PterygiumNCT02009072
Comparison Between Sutureless and Glue Free Versus Sutured Limbal Conjunctival Autograft in Primary Pterygium Surgery
A study testing Sutureless and glue free limbal conjunctival autograft and Sutured limbal conjunctival autograft in people with Pterygium, run by Shaaban Elwan at 1 site in Egypt.
Trial summary
Pterygium is a common ocular pathology facing ophthalmologists that has varied surgical management techniques and high rate of post-operative recurrence. The investigators aim was to compare and evaluate the safety and efficacy outcomes of those two surgical procedures in management of primary pterygium. Read more about this study
- Who is it for?
- Ages 24 to 74 years
- Conditions the study is for
- Pterygium
- What is being tested?
- Sutureless and glue free limbal conjunctival autograft and Sutured limbal conjunctival autograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2010to Nov 2012
- 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 24 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients complaining of primary pterygium with eye redness. Patients with pterygium threatening the visual axis.
Who cannot join
- All cases not completed the follow up period for two years. Atrophic pterygium, pseudopterygium or double head pterygium.
Trial locations and contacts
1 site in 1 country.
About this study
Pterygium is a common ocular pathology facing ophthalmologists that has varied surgical management techniques and high rate of post-operative recurrence. The investigators aim was to compare and evaluate the safety and efficacy outcomes of those two surgical procedures in management of primary pterygium.
Read the detailed description
Design: Prospective randomized clinical trial comparative study. Setting: Department of ophthalmology, Al-Minia University Faculty of medicine, Egypt.
Methods: The study included 150 eyes of 150 patients of primary pterygium. Twenty four to 74 years of age (mean 49 ± 12 years). Simple excision under local anesthesia was performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 50 eyes of 50 patients (group 1), versus sutured free conjunctival autograft in 100 eyes of 100 patients (group 2).
- Conditions
- Pterygium
- Being tested
- Sutureless and glue free limbal conjunctival autograft, Sutured limbal conjunctival autograft
- Keywords
- Pterygium surgery, Sutureless glue free conjunctival autograft, Amniotic membrane graft.
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sutureless and glue free limbal conjunctival autograftProcedure or surgery
Also called Sutureless and glue free LCAG
Simple pterygium excision under local anesthesia was performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 50 eyes of 50 patients (group 1)
Sutured limbal conjunctival autograftProcedure or surgery
Also called Sutured LCAG
Simple pterygium excision under local anesthesia was performed then closure of the bare sclera by sutured limbal conjunctival autograft in 100 eyes of 100 patients (group 2).
| Study group | Role | What they receive |
|---|---|---|
| Sutured limbal conjunctival autograft | Experimental | Sutured limbal conjunctival autograft was done for patients of group 2 after pterygium excision Receives: Procedure: Sutured limbal conjunctival autograft |
| Suturless and glue free Limbal conjuctival autograft | Experimental | Sutureless and glue free Limbal conjunctival autograft was done for patients of group 1 after pterygium excision Receives: Procedure: Sutureless and glue free limbal 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 which was defined as fibrovascular proliferation invading the cornea more than 1.5 mm at the site of previously excised pterygium.
Measured: 24 months
Secondary outcomes (3)
Postoperative signs and symptoms
The secondary outcomes measure, postoperative pain, foreign body sensation, photophobia, hyperemia and chemosis.
Measured: Third postoperative day,then weekly for one month
Overall patient satisfaction
Overall satisfaction with the procedure 3 weeks post-operatively was 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 two groups were compared for overall satisfaction.
Measured: Third post-operative week
Complications
Complications was recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startApr 2010
- Primary completionOct 2010
- Study completionNov 2012
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.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaaban Elwan
- Sponsor type
- University, hospital or other
- Collaborators
- Minia University
- Responsible party
- Sponsor-investigator, Shaaban Elwan, Minia University
- Investigators
- Shaaban A Elwan, Assist Prof Ophth, Principal investigator, Ophthalmology Dep., Al-Minya University Hospitals, Al-Minya, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009072
- Sponsor's protocol ID
- Pterygium Surgery
- Status last verified
- Jan 2014
- First submitted
- 2 Dec 2013
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Sutureless and Glue Free Versus Sutured Limbal Conjunctival Autograft in Primary Pterygium Surgery
- ClinicalTrials.gov ID
- NCT02009072
- Acronym / sponsor ID
- Pterygium Surgery
- Conditions
- Pterygium
- Keywords
- Pterygium surgery, Sutureless glue free conjunctival autograft, Amniotic membrane graft.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Shaaban ElwanUniversity, hospital or other
- Collaborators
- Minia University
- Study start
- Apr 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 11 Dec 2013 (estimated)
- 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 common ocular pathology facing ophthalmologists that has varied surgical management techniques and high rate of post-operative recurrence. The investigators aim was to compare and evaluate the safety and efficacy outcomes of those two surgical procedures in management of primary pterygium.
Detailed description
Design: Prospective randomized clinical trial comparative study. Setting: Department of ophthalmology, Al-Minia University Faculty of medicine, Egypt.
Methods: The study included 150 eyes of 150 patients of primary pterygium. Twenty four to 74 years of age (mean 49 ± 12 years). Simple excision under local anesthesia was performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 50 eyes of 50 patients (group 1), versus sutured free conjunctival autograft in 100 eyes of 100 patients (group 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sutured limbal conjunctival autograft | Experimental | Procedure: Sutured limbal conjunctival autograftSutured limbal conjunctival autograft was done for patients of group 2 after pterygium excision |
| Suturless and glue free Limbal conjuctival autograft | Experimental | Procedure: Sutureless and glue free limbal conjunctival autograftSutureless and glue free Limbal conjunctival autograft was done for patients of group 1 after pterygium excision |
Who may qualify
- Ages
- 24 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients complaining of primary pterygium with eye redness. Patients with pterygium threatening the visual axis.
Key exclusion criteria (1 listed)
- All cases not completed the follow up period for two years. Atrophic pterygium, pseudopterygium or double head 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 |
|---|---|---|
| Sutureless and glue free limbal conjunctival autograftAlso: Sutureless and glue free LCAGSimple pterygium excision under local anesthesia was performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 50 eyes of 50 patients (group 1) | Procedure or surgery | Suturless and glue free Limbal conjuctival autograft |
| Sutured limbal conjunctival autograftAlso: Sutured LCAGSimple pterygium excision under local anesthesia was performed then closure of the bare sclera by sutured limbal conjunctival autograft in 100 eyes of 100 patients (group 2). | Procedure or surgery | Sutured limbal conjunctival autograft |
Primary outcome
Recurrence Rate
Time frame: 24 months
The main postoperative primary outcomes measure the recurrence rate which was defined as fibrovascular proliferation invading the cornea more than 1.5 mm at the site of previously excised pterygium.
3 secondary outcomes
Postoperative signs and symptoms
Time frame: Third postoperative day,then weekly for one month
Overall patient satisfaction
Time frame: Third post-operative week
Complications
Time frame: 24 months
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 7 Jan 2014.
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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.
Shaaban A Elwan, Assist Prof Ophth principal investigator
Ophthalmology Dep., Al-Minya University Hospitals, Al-Minya, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sutureless and glue free limbal conjunctival autograft and Sutured limbal conjunctival autograft in people with Pterygium, run by Shaaban Elwan 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 1 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 7 Jan 2014. 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?
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: 24 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 7 Jan 2014.