NCT03626675

Brief Summary

  1. 1.Develop a measurement protocol by OCT imaging and characterization of the anterior chamber change in glaucoma patients before and after surgery.
  2. 2.Show the effect of combined surgery in control of intra ocular pressure.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

October 9, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

August 7, 2018

Last Update Submit

October 6, 2018

Conditions

Angle Closure GlaucomaGlaucomaCataract Secondary

Outcome Measures

Primary Outcomes (1)

  • Biometric parameters measured with the AS-OCT (AC depth (ACD)) after surgery. - anterior chamber depth in mm

    anterior chamber depth in mm Distance from corneal endothelium to anterior surface of the lens

    one week post operative

Secondary Outcomes (2)

  • other biometric parameters measured with the AS-OCT,

    1,3,6, month postoperative

  • intra ocular pressure

    1,3,6, month postoperative

Study Arms (1)

study group

OTHER

They will be subjected to: Preoperative A-complete ophthalmic examination will be done for every patient; B- Biometric parameters measured with the AS-OCT C- Medical fitness for all patients D- Informed consent will be obtained from all patients after through explanation of operation and its potential benefits and risks. Surgery combined Phaco trabeculectomy Post operative: -Follow-up examinations will be performed for every patient at 1day, 1 week, 1 and 3 months postoperatively. and biometric parameters measured with the AS-OCT before and after the surgery will be used to collect the data. -The data will be managed and analysed with confidentiality by scientifically qualified persons

Procedure: phaco- trabeculectomy

Interventions

phaco- trabeculectomyPROCEDURE

combined phaco-trabeculectomy surgery

study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged over 18 years
  • Diagnosed primary open angle glaucoma
  • Visual field defects and optic nerve head appearance characteristic for glaucoma
  • Angle closure predisposition as evidenced from gonioscopy.
  • Neovascularization in the anterior chamber angle
  • pseudo-exfoliation glaucoma as evidenced from slit lamp examination
  • No cataract surgery.
  • No glaucoma surgery
  • No degenerative changes in the retina in funduscopy after mydriasis

You may not qualify if:

  • previous glaucoma surgery
  • Previous cataract surgery
  • Presence of any abnormalities preventing reliable measurements
  • Ocular inflammation and ocular disease interfering with the study
  • Corneal, macula, and other corneal disease.
  • No fixation Funds lesions such as diabetic retinopathy or retinal detachment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

RECRUITING

Related Publications (4)

  • Salim S. The role of anterior segment optical coherence tomography in glaucoma. J Ophthalmol. 2012;2012:476801. doi: 10.1155/2012/476801. Epub 2012 Aug 1.

    PMID: 22900146RESULT

  • Maslin JS, Barkana Y, Dorairaj SK. Anterior segment imaging in glaucoma: An updated review. Indian J Ophthalmol. 2015 Aug;63(8):630-40. doi: 10.4103/0301-4738.169787.

    PMID: 26576519RESULT

  • Sharma R, Sharma A, Arora T, Sharma S, Sobti A, Jha B, Chaturvedi N, Dada T. Application of anterior segment optical coherence tomography in glaucoma. Surv Ophthalmol. 2014 May-Jun;59(3):311-27. doi: 10.1016/j.survophthal.2013.06.005. Epub 2013 Oct 15.

    PMID: 24138894RESULT

  • Hong CJ, Trope GE. Glaucoma. CMAJ. 2015 Sep 8;187(12):E398-9. doi: 10.1503/cmaj.140401. Epub 2014 Nov 24. No abstract available.

    PMID: 25421984RESULT

MeSH Terms

Conditions

Glaucoma, Angle-ClosureGlaucomaCapsule Opacification

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesCataractLens Diseases

Study Officials

  • Omar M Ali, MD,professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Ehab I Wasfy, professor

CONTACT

01000373344wasfiehab@hotmail.com

Mahmoud F Rateb, Lecturer

CONTACT

01008348480Rateb.eye@gamil.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 13, 2018

Study Start

October 15, 2018

Primary Completion

September 1, 2019

Study Completion

March 1, 2020

Last Updated

October 9, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)