GlaucomaPhase 4NCT00351429
Study of PGA Suture in Ophthalmology
A Phase 4 study testing Polyglycolic acid suture in people with Glaucoma, run by Aurolab at 1 site in India.
Trial summary
To evaluate the safety and efficacy of polyglycolic acid suture in ophthalmic surgical procedures Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma
- What is being tested?
- Polyglycolic acid suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2005to May 2006
- Phase
- Phase 4
- 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 undergoing Trabeculectomy with IOL implantation
- Current residence within 60 kms of madurai
Who cannot join
- Life threatening illness
- Immunosuppressive disorders
- Chronic infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Safety and Efficacy of Polyglycolic Acid Suture in Ophthalmic Surgical Procedures
To evaluate the safety and efficacy of polyglycolic acid suture in ophthalmic surgical procedures
Read the detailed description
The sutures are classified into non-absorbable and absorbable sutures. Violet braided polyglycolic acid suture is the synthetic absorbable suture used in wound closure in ophthalmology, cardiology, neurology and plastic \& reconstructive surgeries. In ophthalmology, PGA sutures are used in Trabeculectomy (Glaucoma), Orbit and Oculoplasty, Lid and Socket Reconstruction, Squint, ptosis and retinal detachment surgeries.
Glaucoma patients who met the inclusion criteria were recruited for this study. Uniform surgery and suturing technique was performed in all patients (Trabeculectomy with IOL implantation). Surgeon assessed suture characteristics during surgery and wound integrity at the end of surgery.
Patients were followed up during 1 day, 1 month and 3 months post operatively. Visual acuity, Intraocular Pressure (IOP), suture characteristics, wound integrity, inflammation and conjunctival status were examined during each follow up visit.
- Conditions
- Glaucoma
- Being tested
- Polyglycolic acid suture
- Keywords
- Glaucoma, Trabeculectomy, Sutures
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyglycolic acid sutureDevice
Also called Aurocryl
PGA suture used in Trabeculectomy surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Polyglycolic acid suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suture characteristics
Measured: 1 month, 3 months
Secondary outcomes (2)
Bleb characteristics
Measured: 1 month, 3 months
Conjunctival status
Measured: 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2006 (estimated)
- Study startOct 2005
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurolab
- Sponsor type
- University, hospital or other
- Investigators
- Ramaswamy Krishnadas, DO, Dip NB, Principal investigator, Aravind Eye Hospital, Madurai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351429
- Sponsor's protocol ID
- 1PN1010510
- Status last verified
- Feb 2009
- First submitted
- 11 Jul 2006
- Last updated
- 11 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Efficacy of Polyglycolic Acid Suture in Ophthalmic Surgical Procedures
- ClinicalTrials.gov ID
- NCT00351429
- Acronym / sponsor ID
- 1PN1010510
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Trabeculectomy, Sutures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AurolabUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 12 Jul 2006 (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.
To evaluate the safety and efficacy of polyglycolic acid suture in ophthalmic surgical procedures
Detailed description
The sutures are classified into non-absorbable and absorbable sutures. Violet braided polyglycolic acid suture is the synthetic absorbable suture used in wound closure in ophthalmology, cardiology, neurology and plastic \& reconstructive surgeries. In ophthalmology, PGA sutures are used in Trabeculectomy (Glaucoma), Orbit and Oculoplasty, Lid and Socket Reconstruction, Squint, ptosis and retinal detachment surgeries.
Glaucoma patients who met the inclusion criteria were recruited for this study. Uniform surgery and suturing technique was performed in all patients (Trabeculectomy with IOL implantation). Surgeon assessed suture characteristics during surgery and wound integrity at the end of surgery.
Patients were followed up during 1 day, 1 month and 3 months post operatively. Visual acuity, Intraocular Pressure (IOP), suture characteristics, wound integrity, inflammation and conjunctival status were examined during each follow up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Polyglycolic acid suture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing Trabeculectomy with IOL implantation
- Current residence within 60 kms of madurai
Key exclusion criteria (3 listed)
- Life threatening illness
- Immunosuppressive disorders
- Chronic infection
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 |
|---|---|---|
| Polyglycolic acid sutureAlso: AurocrylPGA suture used in Trabeculectomy surgery | Device | 1 |
Primary outcome
Suture characteristics
Time frame: 1 month, 3 months
2 secondary outcomes
Bleb characteristics
Time frame: 1 month, 3 months
Conjunctival status
Time frame: 1 month, 3 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 11 Feb 2009.
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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.
Ramaswamy Krishnadas, DO, Dip NB principal investigator
Aravind Eye Hospital, Madurai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polyglycolic acid suture in people with Glaucoma, run by Aurolab at 1 site in India.
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 3 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 11 Feb 2009. 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 India. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Suture characteristics (time frame: 1 month, 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 11 Feb 2009.