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Completed

NCT Number: NCT04683055

Phaco-Trabeculotomy Vs Phaco-Trabeculectomy

A prospective, randomized comparative study on adult patients with synechial angle closure glaucoma.

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Key information

Conditions

Ophthalmopathy Eye Diseases Glaucoma Glaucoma, Angle-Closure Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hospital

Asyut, 7125, Egypt

About this study

Patients were randomized into two groups: group A : patients will undergo two site phacoemulfication combined with trabeculectomy Group B with Phacoemulsification combined with ab-externo trabeculotomy. Preoperative assessments including full ophthalmic examination, anterior segment Optical Coherence Tomography (OCT) of the angle , endothelial cell count , visual fiend Perimetry and Biometry. Patients were followed up: first day, first week and every two months for 6 month. We will compare adverse effects and outcomes in both groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with chronic angle closure glaucoma, with or without peripheral anterior synechiae, age more than 18

Exclusion criteria

  • Patient unable for follow up
  • Patients with corneal or retinal disease that affects visual outcome of surgery
  • Patients with previous glaucoma procedure in the eye of study

Treatment and study plan

Phacoemulsification combined with trabeculectomy

Procedure

Patients with chronic angle closure glaucoma assigned to this group will have fornex based trabeculectomy at superior limbus and then phacoemulsification via temporal incision

Phacoemulsificaiton combined with ab-externo trabeculotomy

Procedure

Patients with chronic angle closure glaucoma assigned to this group will have Deep Sclerectomy with ab externo trabeculotomy at superior limbus and then phacoemulsification via temporal incision

Primary outcomes

  1. Absolute Success

    Time frame: 1,3,6 months

    Reduction of IOP more than 30% on no glaucoma drops

  2. Visual outcome

    Time frame: 1,3,6 month

    Uncorrected visual acuity by Snellen's chart

Secondary outcomes

  1. Adverse events

    Time frame: 1 week, 1 month, 3 months, 6 months

    all intraoperative and postoperative adverse events witt be recorded

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Phacoemulsification Combined With Trabeculectomy Versus Phacoemulsification Combined With Trabeculotomy for Treatment of Chronic Angle Closure Glaucoma

Acronym: PDT vs PT

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Dec 24, 2020
Registry last updated
Oct 29, 2021

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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