Combined Viscocanalostomy, Phacoemulsification, OIogen Implant in Open Angle Glaucoma (Visco-ologen)

Z

Zagazig University

Status

Completed

Conditions

Primary Open-angle Glaucoma

Treatments

Procedure: combined phacoemulsification and viscocanalostomy and ologen
Procedure: combined phacoemulsification and viscocanalostomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03782051
1102108

Details and patient eligibility

About

This prospective, interventional, randomized clinical study was done at Alpha Vision Center, Zagazig, Egypt. Patients with coexisting cataract and glaucoma were randomized to receive either phaco-viscocanalostomy (Phacovisco group) or phaco-viscocanalostomy with Ologen® implant (OloPhacovisco group) . Follow-up period was 2 years. Nd:YAG laser goniopuncture was done in cases where the intraocular pressure (IOP) was elevated above 21 mmHg after discontinuation of corticosteroid eye drops at any follow-up visit. Our hypothesis is that using Ologen® implant as a spacer in the subscleral reservoir in phaco-viscocanalostomy reduces fibrosis and increase the success rate of this operation

Full description

Background: To study the efficacy of the biodegradable collagen implant Ologen® as an adjuvant in phaco-viscocanalostomy in patients with coexisting cataract and primary open angle glaucoma. Methods: This prospective, interventional, randomized clinical study was done at Alpha Vision Center, Zagazig, Egypt. Patients with coexisting cataract and glaucoma were randomized to receive either phaco-viscocanalostomy (Phacovisco group) or phaco-viscocanalostomy with Ologen® implant (OloPhacovisco group). Follow-up period was 2 years. Nd:YAG laser goniopuncture was done in cases where the intraocular pressure (IOP) was elevated above 21 mmHg after discontinuation of corticosteroid eye drops at any follow-up visit.

Enrollment

81 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • the presence of significant cataract interfering with vision (visual acuity ≤ 0.5) in the presence POAG.
  • if cataract was associated with uncontrolled glaucoma, (IOP > 21 mmHg despite maximally tolerated medical therapy)
  • if the IOP was ≤ 21 mmHg with use of at least two antiglaucoma drugs with medication intolerance
  • poor patient compliance
  • patients could not attend medical supervision
  • patients had visual field deterioration.

Exclusion criteria

  • closed-angle glaucoma
  • other types of open angle glaucoma (OAG), e.g. pigmentary glaucoma, inflammatory glaucoma or neovascular glaucoma,
  • previous ocular trauma or surgery
  • lens subluxation
  • any eye diseases affecting the vision, e.g. anterior uveitis
  • if there was a large perforation of the Descemet's membrane with iris prolapse during surgery (cases with microperforation, which is defined as small perforation with no associated iris prolapse, occurring during surgery were not excluded) intraoperative complications that might affect the IOP, e.g. vitreous loss.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

81 participants in 2 patient groups

Phacovisco group
Active Comparator group
Description:
group had combined phacoemulsification and viscocanalostomy
Treatment:
Procedure: combined phacoemulsification and viscocanalostomy
OloPhacovisco group
Active Comparator group
Description:
group had combined phacoemulsification and viscocanalostomy and Ologen
Treatment:
Procedure: combined phacoemulsification and viscocanalostomy and ologen

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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