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

Primary Purpose

Ophthalmopathy, Glaucoma, Glaucoma, Angle-Closure

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Phacoemulsification combined with trabeculectomy
Phacoemulsificaiton combined with ab-externo trabeculotomy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ophthalmopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assiut University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Phacoemulsification combined with trabeculectomy

Phacoemulsificaiton combined with ab-externo trabeculotomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Absolute Success
Reduction of IOP more than 30% on no glaucoma drops
Visual outcome
Uncorrected visual acuity by Snellen's chart

Secondary Outcome Measures

Adverse events
all intraoperative and postoperative adverse events witt be recorded

Full Information

First Posted
December 20, 2020
Last Updated
October 28, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04683055
Brief Title
Phaco-Trabeculotomy Vs Phaco-Trabeculectomy
Acronym
PDT vs PT
Official Title
Phacoemulsification Combined With Trabeculectomy Versus Phacoemulsification Combined With Trabeculotomy for Treatment of Chronic Angle Closure Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ophthalmopathy, Glaucoma, Glaucoma, Angle-Closure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phacoemulsification combined with trabeculectomy
Arm Type
Active Comparator
Arm Description
Patients will undergo Two site phacoemulsification combined with trabeculectomy with Mitomycin C
Arm Title
Phacoemulsificaiton combined with ab-externo trabeculotomy
Arm Type
Active Comparator
Arm Description
Patients will undergo two phacoemulsification combined with deep sclerectomy and ab-externo trabeculotomy
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification combined with trabeculectomy
Intervention Description
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
Intervention Name(s)
Phacoemulsificaiton combined with ab-externo trabeculotomy
Intervention Description
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
Primary Outcome Measure Information:
Title
Absolute Success
Description
Reduction of IOP more than 30% on no glaucoma drops
Time Frame
1,3,6 months
Title
Visual outcome
Description
Uncorrected visual acuity by Snellen's chart
Time Frame
1,3,6 month
Secondary Outcome Measure Information:
Title
Adverse events
Description
all intraoperative and postoperative adverse events witt be recorded
Time Frame
1 week, 1 month, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
ZIP/Postal Code
7125
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data in the study , after completion after de-identification
IPD Sharing Time Frame
after publication and for five years
IPD Sharing Access Criteria
Anyone who wants to access data
Citations:
PubMed Identifier
11713061
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. doi: 10.1016/s0161-6420(01)00873-9.
Results Reference
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PubMed Identifier
12466166
Citation
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.
Results Reference
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PubMed Identifier
31702714
Citation
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.
Results Reference
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PubMed Identifier
28264221
Citation
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.
Results Reference
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Phaco-Trabeculotomy Vs Phaco-Trabeculectomy

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