Phaco-Trabeculotomy Vs Phaco-Trabeculectomy

NCT04683055 | Completed

• 1 other identifier: IRB17300506
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ophthalmopathy; Glaucoma; Glaucoma, Angle-Closure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Adverse events

  1 week, 1 month, 3 months, 6 months

Study Arms (2)

Phacoemulsification combined with trabeculectomy

ACTIVE COMPARATOR

Patients will undergo Two site phacoemulsification combined with trabeculectomy with Mitomycin C

Procedure: Phacoemulsification combined with trabeculectomy

Phacoemulsificaiton combined with ab-externo trabeculotomy

ACTIVE COMPARATOR

Patients will undergo two phacoemulsification combined with deep sclerectomy and ab-externo trabeculotomy

Procedure: Phacoemulsificaiton combined with ab-externo trabeculotomy

Interventions

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

Phacoemulsification combined with trabeculectomy

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

Phacoemulsificaiton combined with ab-externo trabeculotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 7125, Egypt

Location

Related Publications (4)

• 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.

  PMID: 11713061 BACKGROUND

• 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.

  PMID: 12466166 BACKGROUND

• 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.

  PMID: 31702714 BACKGROUND

• 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.

  PMID: 28264221 BACKGROUND

MeSH Terms

Conditions

Eye Diseases; Glaucoma; Glaucoma, Angle-Closure

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular Hypertension

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professor of Ophthalmology

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: December 24, 2020
• Study Start: October 28, 2020
• Primary Completion: December 31, 2020
• Study Completion: May 1, 2021
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after publication and for five years
• Access Criteria: Anyone who wants to access data

Locations

EG (1)