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CompletedNCT04683055PDT vs PTUpdated Oct 29, 2021

Phaco-Trabeculotomy Vs Phaco-Trabeculectomy

An interventional study of Phacoemulsification combined with trabeculectomy and Phacoemulsificaiton combined with ab-externo trabeculotomy in Ophthalmopathy, Glaucoma and Glaucoma, Angle-Closure, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-29.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Ophthalmopathy
  • Glaucoma
  • Glaucoma, Angle-Closure
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Phacoemulsification combined with trabeculectomy

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

    Procedure: Phacoemulsification combined with trabeculectomy

  • Active comparator
    Phacoemulsificaiton combined with ab-externo trabeculotomy

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

    Procedure: Phacoemulsificaiton combined with ab-externo trabeculotomy

Interventions

  • ProcedurePhacoemulsification 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

  • ProcedurePhacoemulsificaiton 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

05

What researchers measure

Primary outcomes

  1. Absolute Success

    Reduction of IOP more than 30% on no glaucoma drops

    Time frame: 1,3,6 months

  2. Visual outcome

    Uncorrected visual acuity by Snellen's chart

    Time frame: 1,3,6 month

Secondary outcomes

  1. Adverse events

    all intraoperative and postoperative adverse events witt be recorded

    Time frame: 1 week, 1 month, 3 months, 6 months

06

Study locations

1 site
  • Assiut University Hospital
    Assiut, 7125, Egypt
07

References and documents

Publications

  • 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. PubMed 11713061 ↗
  • 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. PubMed 12466166 ↗
  • 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. PubMed 31702714 ↗
  • 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. PubMed 28264221 ↗

Individual participant data

Plan to share: Yes — All of the individual participant data in the study , after completion after de-identification

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

08

Registry details

Key details

Study ID
NCT04683055
Lead sponsor
Assiut University
Responsible party
Mahmoud F. Rateb (Assitant Professor of Ophthalmology, Assiut University) — Principal investigator
First posted
Dec 24, 2020
Start date
Oct 28, 2020
Primary completion
Dec 31, 2020
Completion
May 1, 2021
Last update
Oct 29, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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