PDT vs PT: Phaco-Trabeculotomy Vs Phaco-Trabeculectomy

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT04683055
Collaborator
(none)
50
1
2
6.1
8.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Phacoemulsification combined with trabeculectomy
  • Procedure: Phacoemulsificaiton combined with ab-externo trabeculotomy
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phacoemulsification Combined With Trabeculectomy Versus Phacoemulsification Combined With Trabeculotomy for Treatment of Chronic Angle Closure Glaucoma
Actual Study Start Date :
Oct 28, 2020
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Phacoemulsification combined with trabeculectomy

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

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

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
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

Outcome Measures

Primary Outcome Measures

  1. Absolute Success [1,3,6 months]

    Reduction of IOP more than 30% on no glaucoma drops

  2. Visual outcome [1,3,6 month]

    Uncorrected visual acuity by Snellen's chart

Secondary Outcome Measures

  1. Adverse events [1 week, 1 month, 3 months, 6 months]

    all intraoperative and postoperative adverse events witt be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Hospital Assiut Egypt 7125

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mahmoud F. Rateb, Assitant Professor of Ophthalmology, Assiut University
ClinicalTrials.gov Identifier:
NCT04683055
Other Study ID Numbers:
  • IRB17300506
First Posted:
Dec 24, 2020
Last Update Posted:
Oct 29, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 29, 2021