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

• ClinicalTrials.gov Identifier: NCT04683055
• Recruitment Status: Completed
• First Posted: December 24, 2020
• Last Update Posted: October 29, 2021
• Sponsor: Assiut University
• Information provided by (Responsible Party): Mahmoud F. Rateb, Assiut University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Ophthalmopathy; Glaucoma; Glaucoma, Angle-Closure	Procedure: Phacoemulsification combined with trabeculectomy; Procedure: Phacoemulsificaiton combined with ab-externo trabeculotomy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phacoemulsification Combined With Trabeculectomy Versus Phacoemulsification Combined With Trabeculotomy for Treatment of Chronic Angle Closure Glaucoma
• Actual Study Start Date: October 28, 2020
• Actual Primary Completion Date: December 31, 2020
• Actual Study Completion Date: May 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Adverse events [ Time Frame: 1 week, 1 month, 3 months, 6 months ]
   all intraoperative and postoperative adverse events witt be recorded

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Egypt

Assiut University Hospital

Assiut, Egypt, 7125

Sponsors and Collaborators

Assiut University

More Information

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.

Rebolleda G, Muñoz-Negrete FJ. Phacoemulsification in eyes with functioning filtering blebs: a prospective study. Ophthalmology. 2002 Dec;109(12):2248-55.

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.

Töteberg-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.

• Responsible Party: Mahmoud F. Rateb, Assitant Professor of Ophthalmology, Assiut University
• ClinicalTrials.gov Identifier: NCT04683055
• Other Study ID Numbers: IRB17300506
• First Posted: December 24, 2020
• Last Update Posted: October 29, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All of the individual participant data in the study , after completion after de-identification
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: after publication and for five years
• Access Criteria: Anyone who wants to access data

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Glaucoma; Eye Diseases; Glaucoma, Angle-Closure; Ocular Hypertension