Phaco-Trabeculotomy Vs Phaco-Trabeculectomy (PDT vs PT)

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

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

Study Overview

• Status: Completed
• Conditions: Glaucoma; Glaucoma, Angle-Closure; Ophthalmopathy
• Intervention / Treatment: Procedure: Phacoemulsification combined with trabeculectomy; Procedure: Phacoemulsificaiton combined with ab-externo trabeculotomy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 7125
    • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Phacoemulsification combined with trabeculectomy; Patients will undergo Two site phacoemulsification combined with trabeculectomy with Mitomycin C	Procedure: Phacoemulsification combined with trabeculectomy; Patients with chronic angle closure glaucoma assigned to this group will have fornex based trabeculectomy at superior limbus and then phacoemulsification via temporal incision
ACTIVE_COMPARATOR: Phacoemulsificaiton combined with ab-externo trabeculotomy; Patients will undergo two phacoemulsification combined with deep sclerectomy and ab-externo trabeculotomy	Procedure: Phacoemulsificaiton combined with ab-externo trabeculotomy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Success	Reduction of IOP more than 30% on no glaucoma drops	1,3,6 months
Visual outcome	Uncorrected visual acuity by Snellen's chart	1,3,6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	all intraoperative and postoperative adverse events witt be recorded	1 week, 1 month, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Lichter PR, Musch DC, Gillespie BW, Guire KE, Janz NK, Wren PA, Mills RP; CIGTS Study Group. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology. 2001 Nov;108(11):1943-53. doi: 10.1016/s0161-6420(01)00873-9.
• Rebolleda G, Munoz-Negrete FJ. Phacoemulsification in eyes with functioning filtering blebs: a prospective study. Ophthalmology. 2002 Dec;109(12):2248-55. doi: 10.1016/s0161-6420(02)01246-0.
• Hansapinyo L, Choy BNK, Lai JSM, Tham CC. Phacoemulsification Versus Phacotrabeculectomy in Primary Angle-closure Glaucoma With Cataract: Long-Term Clinical Outcomes. J Glaucoma. 2020 Jan;29(1):15-23. doi: 10.1097/IJG.0000000000001397.
• Toteberg-Harms M, Wachtl J, Schweier C, Funk J, Kniestedt C. Long-term efficacy of combined phacoemulsification plus trabeculectomy versus phacoemulsification plus excimer laser trabeculotomy. Klin Monbl Augenheilkd. 2017 Apr;234(4):457-463. doi: 10.1055/s-0043-100291. Epub 2017 Mar 6.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 28, 2020
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): May 1, 2021

Study Registration Dates

• First Submitted: December 20, 2020
• First Submitted That Met QC Criteria: December 20, 2020
• First Posted (ACTUAL): December 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ocular Hypertension; Glaucoma; Eye Diseases; Glaucoma, Angle-Closure
• Other Study ID Numbers: IRB17300506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data in the study , after completion after de-identification
• IPD Sharing Time Frame: after publication and for five years
• IPD Sharing Access Criteria: Anyone who wants to access data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No