Phaco-Trabeculotomy Vs Phaco-Trabeculectomy

NCT ID: NCT04683055

Last Updated: 2021-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-28

Study Completion Date

2021-05-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Ophthalmopathy Glaucoma Glaucoma, Angle-Closure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phacoemulsification combined with trabeculectomy

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

Group Type ACTIVE_COMPARATOR

Phacoemulsification combined with trabeculectomy

Intervention Type 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

Phacoemulsificaiton combined with ab-externo trabeculotomy

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

Group Type ACTIVE_COMPARATOR

Phacoemulsificaiton combined with ab-externo trabeculotomy

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud F. Rateb

Assitant Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University Hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 11713061 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12466166 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31702714 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28264221 (View on PubMed)

Other Identifiers

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IRB17300506

Identifier Type: -

Identifier Source: org_study_id