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Completed

NCT Number: NCT03782051

Combined Viscocanalostomy, Phacoemulsification, OIogen Implant in Open Angle Glaucoma

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alpha vision center

Zagazig, Al Sharkeya, 44511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

combined phacoemulsification and viscocanalostomy

Procedure

phacoemulsification with viscocanalostomy

Other names: phaco-visco-canalostomy

combined phacoemulsification and viscocanalostomy and ologen

Procedure

phacoemulsification with viscocanalostomy with ologen

Other names: phaco-visco-canalostomy with ologen implant

Primary outcomes

  1. the intraocular pressure

    Time frame: 2 years

    measured by mmHg using Goldman applanatin tonometry

Secondary outcomes

  1. surgical complications

    Time frame: 2 years

    number of surgical complications encountered

  2. the use and results of Nd:YAG laser goniopuncture

    Time frame: 2 years

    number of cases needed goniopuncture

  3. visual acuity results

    Time frame: 2 years

    visual acuity measured by decimal system

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Combined Phacoemulsification and Viscocanalostomy With Ologen Implant Versus Combined Phacoemulsification and Viscocanalostomy

Acronym: Visco-ologen

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2018
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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