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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04683055
Other study ID # IRB17300506
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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