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Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery

Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00538590
Enrollment
20
Registered
2007-10-02
Start date
2007-07-31
Completion date
2010-08-31
Last updated
2012-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Angle Glaucoma

Keywords

ologen, collagen matrix, glaucoma, trabeculectomy, Mitomycin-C

Brief summary

To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) in glaucoma surgery.

Detailed description

To compare the safety and effectiveness in between oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) for glaucoma surgery. The surgery is performed by the gold standard of trabeculectomy. Mitomycin-C(MMC) is applied for those who not collagen matrix implanted.

Interventions

DEVICECollagen Matrix in Glaucoma Filtering Surgery

Collagen Matrix implantation in Glaucoma Filtering Surgery

DRUGMitomycin-C(MMC) and glaucoma filtering surgery

If mitomycin -C is applied, a single cellulose sponge soaked with Mitomycin-C(MMC) (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.

Sponsors

Pro Top & Mediking Company Limited
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Open angle glaucoma * Maxima anti-glaucoma medication failed * Age\>18 * Able to complete the follow up

Exclusion criteria

* Topical eye inflammation * Angle closure glaucoma * Deformity glaucoma * One eye glaucoma * Previous conjunctiva opened * Allergy to collagen

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Intraocular Pressure Change360 daysPostoperative intraocular pressure change at 360 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.

Secondary

MeasureTime frameDescription
Complications360 daysIncidence (percentage) for complications recorded: Hyphema, early hypotony(\<7days), late hypotony(\>7days), shallow anterior chamber, choroidal detachment, early leak(\<7days), late leak(\>7days), Tenon's cysts, and revision surgery for up to 360 days.

Countries

Germany

Participant flow

Participants by arm

ArmCount
MITOMYCIN-C
Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
10
Ologen (Oculusgen)
The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
10
Total20

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath10

Baseline characteristics

CharacteristicOlogen (Oculusgen)MITOMYCIN-CTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
5 Participants5 Participants10 Participants
Age, Categorical
Between 18 and 65 years
5 Participants5 Participants10 Participants
Age Continuous64.9 years
STANDARD_DEVIATION 8.6
60.6 years
STANDARD_DEVIATION 9.4
62.8 years
STANDARD_DEVIATION 9.5
Region of Enrollment
Germany
10 participants10 participants20 participants
Sex: Female, Male
Female
6 Participants6 Participants12 Participants
Sex: Female, Male
Male
4 Participants4 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 100 / 10
serious
Total, serious adverse events
1 / 100 / 10

Outcome results

Primary

Postoperative Intraocular Pressure Change

Postoperative intraocular pressure change at 360 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.

Time frame: 360 days

ArmMeasureValue (MEAN)Dispersion
MITOMYCIN-CPostoperative Intraocular Pressure Change-11.3 mm HgStandard Deviation 8.7
Ologen (Oculusgen)Postoperative Intraocular Pressure Change-11.6 mm HgStandard Deviation 9.9
Comparison: Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.p-value: 0.95ANOVA
Primary

Postoperative Intraocular Pressure Change

Postoperative intraocular pressure change at 180 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.

Time frame: 180 days

ArmMeasureValue (MEAN)Dispersion
MITOMYCIN-CPostoperative Intraocular Pressure Change-11.8 mm HgStandard Deviation 6.1
Ologen (Oculusgen)Postoperative Intraocular Pressure Change-11.8 mm HgStandard Deviation 11.2
Comparison: Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.p-value: 1ANOVA
Primary

Postoperative Intraocular Pressure Change

Postoperative intraocular pressure change at 90 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.

Time frame: 90 days

ArmMeasureValue (MEAN)Dispersion
MITOMYCIN-CPostoperative Intraocular Pressure Change-10.9 mm HgStandard Deviation 5.8
Ologen (Oculusgen)Postoperative Intraocular Pressure Change-14.1 mm HgStandard Deviation 10.1
Comparison: Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.p-value: 0.4ANOVA
Primary

Postoperative Intraocular Pressure Change

Postoperative intraocular pressure change at 30 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.

Time frame: 30 days

ArmMeasureValue (MEAN)Dispersion
MITOMYCIN-CPostoperative Intraocular Pressure Change-13.3 mm HgStandard Deviation 6.4
Ologen (Oculusgen)Postoperative Intraocular Pressure Change-12.9 mm HgStandard Deviation 8.6
Comparison: Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.p-value: 0.91ANOVA
Secondary

Complications

Incidence (percentage) for complications recorded: Hyphema, early hypotony(\<7days), late hypotony(\>7days), shallow anterior chamber, choroidal detachment, early leak(\<7days), late leak(\>7days), Tenon's cysts, and revision surgery for up to 360 days.

Time frame: 360 days

ArmMeasureValue (MEAN)Dispersion
MITOMYCIN-CComplications15.6 percentage of participantsStandard Deviation 10.1
Ologen (Oculusgen)Complications15.6 percentage of participantsStandard Deviation 20.1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026