Ologen (OculusGen)-Phacotrabeculectomy Historical Control Study in India

An observational study of Glaucoma and Cataract, run by Pro Top & Mediking Company Limited at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

1. . Study Objective: The objective of this study is to determine the safety and effectiveness of the OculusGenTM Biodegradable Collagen Matrix Implant in phacotrabeculectomy surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Cataract
What is being tested?: OculusGen Biodegradable Collagen Matrix Implant
Type of treatment: Medical device
How many people: 10 participants
Where: 1 siteIndia
Study dates: May 2007to Oct 2011
How long will I take part?: 3 Months
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 10

Subject inclusion criteria:

Age 18 years or over.
At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.
Visually significant cataract with visual acuity of less than or equal to 6/12.
Subject able and willing to cooperate with investigation plan.
Subject willing to sign informed consent form.

Subject exclusion criteria:

Known allergic reaction to collagen.
Subject is on Warfarin and discontinuation is not recommended.
Subject with normal tension glaucoma or aphakic glaucoma.
Subject with corneal disease.
Participation in an investigational study during the 30 days proceeding phacotrabeculectomy.
Ocular infection within 14 days prior to phacotrabeculectomy.
Pregnant or breast-feeding women.
Monocular subject.

Trial locations and contacts

1 site in 1 country.

India1 site

Grewal Eye Institute
Chandigarh, 500 034

Other trials in India

About this study

Official title: Study of the Safety and Effectiveness of the OculusGenTM Collagen Matrix Implant as an Aid in Phacotrabeculectomy Surgery

. Study Objective: The objective of this study is to determine the safety and effectiveness of the OculusGenTM Biodegradable Collagen Matrix Implant in phacotrabeculectomy surgery. The primary endpoint is to prove the effectiveness via the reduction of Intraocular Pressure, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events.
. Study Design: The study is designed as a historical controlled study. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study. The allocation of subjects is non-randomized, and there is a single group for assignment.
. Follow-Up: This investigation is including 7 post-operative visits and follow-up within 6 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 14, 30, 60, 90 and 180. The visit window of ± 7 days is allowed for the 30, 60, 90 and 180 day visits. The further follow-up of subject after trial is continually tracked by the investigator.

Read the detailed description

ologen collagen matrix is applied for the phacotrabec surgery.

Conditions: Glaucoma, Cataract
Being tested: OculusGen Biodegradable Collagen Matrix Implant
Keywords: Glaucoma, Collagen matrix, OculusGen, Phacotrabeculectomy, anti scarring, tissue engineering, ologen, Aeon Astron
Medical subject headings: Glaucoma, Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OculusGen Biodegradable Collagen Matrix ImplantDevice
OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.

Study groups in NCT00477685
Study group	Role	What they receive
OculusGen Collagen Matrix		OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy. Receives: Device: OculusGen Biodegradable Collagen Matrix Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

Preoperative and Postoperative Intraocular Pressure
The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days.
Measured: baseline and 90 days

Secondary outcomes (1)

Number of Participants With Any Complications or Adverse Events.
Observation of the incidence of complications, including transient shallow anterior chamber, hyphema, choroidal detachment, hypotony or endophthalmitis.
Measured: 180 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Oct 2011

First posted24 May 2007 (estimated)
Study startMay 2007
Primary completionOct 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 10 participants (actual)
Target duration: 3 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT00477685
Sponsor's protocol ID: Mediking 0704
Other IDs: OculusGen-2007-04-20
Status last verified: Jul 2017
First submitted: 23 May 2007
Last updated: 14 Aug 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

Chen HS, Ritch R, Krupin T, Hsu WC. Control of filtering bleb structure through tissue bioengineering: An animal model. Invest Ophthalmol Vis Sci. 2006 Dec;47(12):5310-4. doi: 10.1167/iovs.06-0378.
PubMed 17122118
Hsu WC, Spilker MH, Yannas IV, Rubin PA. Inhibition of conjunctival scarring and contraction by a porous collagen-glycosaminoglycan implant. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2404-11.
PubMed 10937547

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Safety and Effectiveness of the OculusGenTM Collagen Matrix Implant as an Aid in Phacotrabeculectomy Surgery
ClinicalTrials.gov ID: NCT00477685
Acronym / sponsor ID: Mediking 0704
Conditions: Glaucoma, Cataract
Keywords: Glaucoma, Collagen matrix, OculusGen, Phacotrabeculectomy, anti scarring, tissue engineering, ologen, Aeon Astron
Study type: Observational
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Pro Top & Mediking Company LimitedIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 24 May 2007 (estimated)
Results: Posted 29 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

. Study Objective: The objective of this study is to determine the safety and effectiveness of the OculusGenTM Biodegradable Collagen Matrix Implant in phacotrabeculectomy surgery. The primary endpoint is to prove the effectiveness via the reduction of Intraocular Pressure, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events.
. Study Design: The study is designed as a historical controlled study. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study. The allocation of subjects is non-randomized, and there is a single group for assignment.
. Follow-Up: This investigation is including 7 post-operative visits and follow-up within 6 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 14, 30, 60, 90 and 180. The visit window of ± 7 days is allowed for the 30, 60, 90 and 180 day visits. The further follow-up of subject after trial is continually tracked by the investigator.

Detailed description

ologen collagen matrix is applied for the phacotrabec surgery.

Study design

Observational model: Case only
Time perspective: Prospective
Target follow-up: 3 Months
Number of arms: 1

Arm	Type	Receives
OculusGen Collagen Matrix	–	Device: OculusGen Biodegradable Collagen Matrix ImplantOculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 10

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
OculusGen Biodegradable Collagen Matrix ImplantOculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.	Device	OculusGen Collagen Matrix

Primary outcome

Preoperative and Postoperative Intraocular Pressure
Time frame: baseline and 90 days
The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days.

1 secondary outcome

Number of Participants With Any Complications or Adverse Events.
Time frame: 180 day

Results and safety

Results posted to the registry on 29 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OculusGen Collagen Matrix	10	10

Primary outcome: Preoperative and Postoperative Intraocular Pressure

Time frame: baseline and 90 days. Mean (Standard Deviation). Unit: mm Hg

Measure	OculusGen Collagen Matrix n = 10
Preoperative intraocular pressure	20.1 (8.02)
Postoperative intraocular pressure	9 (3.32)

OculusGen Collagen Matrix: p = 0.01, t-test, 2 sided

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 90 days after surgery.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OculusGen Collagen Matrix	0 of 10 (0%)	0 of 10 (0%)	Not reported

Limitations and caveats (from the sponsor): Limited sample size.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 17122118Chen HS, Ritch R, Krupin T, Hsu WC. Control of filtering bleb structure through tissue bioengineering: An animal model. Invest Ophthalmol Vis Sci. 2006 Dec;47(12):5310-4. doi: 10.1167/iovs.06-0378.
Results publication: PubMed 10937547Hsu WC, Spilker MH, Yannas IV, Rubin PA. Inhibition of conjunctival scarring and contraction by a porous collagen-glycosaminoglycan implant. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2404-11.

Related trials for Glaucoma

Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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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.

SPS Grewal, MD principal investigator

Grewal Eye Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma and Cataract, run by Pro Top & Mediking Company Limited 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?

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 14 Aug 2017. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Preoperative and Postoperative Intraocular Pressure (time frame: baseline and 90 days). 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 NCT00477685, which also lists 2 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 14 Aug 2017; AzTrials last refreshed its copy on 2 Nov 2026.