Phaco-Trabeculotomy Vs Phaco-Trabeculectomy

Glaucoma Clinical Trial

— PDT vs PT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04683055
• Other study ID #: IRB17300506
• Status: Completed
• Phase: N/A
• Start date: October 28, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: October 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Glaucoma
• Glaucoma, Angle-Closure
• Ophthalmopathy

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Success	Reduction of IOP more than 30% on no glaucoma drops	1,3,6 months
Primary	Visual outcome	Uncorrected visual acuity by Snellen's chart	1,3,6 month
Secondary	Adverse events	all intraoperative and postoperative adverse events witt be recorded	1 week, 1 month, 3 months, 6 months