NCT04143620

Brief Summary

Background: One of the most difficult refractory glaucomas in treatment is the neovascular type and its association with dense cataract add to this difficulty. This study aimed to provide results of triple surgical treatment of such conditions. Methods: A total of 12 eyes of 12 patients with dense cataractus NVG patients were included in this study. The patients mean age was 57.25 ± 5.9 years. The mean pre-operative intraocular pressure (IOP) was 47.25 ± 4.04 mmHg with maximum antiglaucoma therapy. The mean best corrected distant visual acuities (BCDVA) in log MAR was 2.13 ± 0.38. All the patients received intra-vitreal injection of 1.25 mg (0.05 ml) bevacizumab followed by phacoemulsification, pars plana vitrectomy (PPV) including pan-retinal photocoagulation (PRP), and assisted trabeculectomy with Mitomycin c (MMC). Mean IOP and BCDVA changes were the main outcome results of this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
Last Updated

January 13, 2020

Status Verified

October 1, 2019

Enrollment Period

3.2 years

First QC Date

October 27, 2019

Last Update Submit

January 10, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • BCDVA

    Best corrected distant visual acuity

    2 years

  • IOP

    Intra-ocular pressure

    2 years

Secondary Outcomes (1)

  • Post-operative complications

    2 years

Study Arms (1)

Neovascular glaucoma

OTHER

Neovascular glaucoma patients underwent triple procedure

Procedure: Procedure

Interventions

ProcedurePROCEDURE

Triple procedure

Also known as: Triple procedure
Neovascular glaucoma

Eligibility Criteria

Age47 Years - 66 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study included patients with uncontrolled angle closure dense cataractus NVG with maximum tolerated anti-glaucoma medications.

You may not qualify if:

  • Excluded from this study eyes that had previous anti-glaucoma procedures, silicone oil filled eyes, previous buckle surgery or Conjunctival scaring from any cause, eyes with clear crystalline lens or faint cataract, eyes with corneal opacity, and eyes with visual acuity less than hand motion with good perception of light.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, 61519, Egypt

Location

Related Publications (1)

  • Moharram HM, Abd-Elhamid Mehany Elwan S, Nassar MM, Abdelkader MF. Triple Procedure for Dense Cataractous Neovascular Glaucoma Patients. J Ophthalmol. 2020 Jun 21;2020:1251203. doi: 10.1155/2020/1251203. eCollection 2020.

MeSH Terms

Conditions

Ocular HypotensionVision Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Eye DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Hossam M Moharram, MD

    Minia University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Manegment of uncontrolled NVG patients with dense cataract
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of ophthalmology

Study Record Dates

First Submitted

October 27, 2019

First Posted

October 29, 2019

Study Start

July 1, 2016

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

January 13, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share

Results of the study

Shared Documents
CSR
Time Frame
2 years
Access Criteria
study results

Locations