NCT04921098

Brief Summary

The purpose of this study is to assess the relative effectiveness and safety of diode laser cyclophotocoagulation procedure to reduce IOP and relieve pain in adult patients with refractory glaucoma.

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
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

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

May 30, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

May 30, 2021

Last Update Submit

January 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • change in intraocular pressure

    IOP measuring using Goldmann applanation tonometer.

    First day postoperative and 1 week

Study Arms (1)

Refractory glaucoma

EXPERIMENTAL
Procedure: Diode Laser Cyclophotocoagulation

Interventions

A handpiece (G probe) is used to deliver the diode laser energy with a wavelength of 810 nm.

Refractory glaucoma

Eligibility Criteria

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

You may qualify if:

  • Patients with refractory glaucoma aging 18 years and older.
  • Both sexes are included.
  • Patients Capable of giving informed consent.
  • Pseudophkic glaucoma.
  • Aphakic glaucoma.
  • Silicon oil induced glaucoma.
  • Neovascular glaucoma.
  • Inflammatory glaucoma.

You may not qualify if:

  • Patients \<18 years of age.
  • Patients controlled on regular antiglaucomatous therapy.
  • Patients who cannot do regular follow up visits.
  • Diffuse scleral staphyloma at the site of CPC.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Egypt

RECRUITING

Related Publications (3)

  • Ansari E, Gandhewar J. Long-term efficacy and visual acuity following transscleral diode laser photocoagulation in cases of refractory and non-refractory glaucoma. Eye (Lond). 2007 Jul;21(7):936-40. doi: 10.1038/sj.eye.6702345. Epub 2006 Apr 21.

    PMID: 16628239BACKGROUND
  • Lai JS, Tham CC, Chan JC, Lam DS. Diode laser transscleral cyclophotocoagulation in the treatment of chronic angle-closure glaucoma: a preliminary study. J Glaucoma. 2003 Aug;12(4):360-4. doi: 10.1097/00061198-200308000-00011.

    PMID: 12897582BACKGROUND
  • Nassiri N, Kamali G, Rahnavardi M, Mohammadi B, Nassiri S, Rahmani L, Nassiri N. Ahmed glaucoma valve and single-plate Molteno implants in treatment of refractory glaucoma: a comparative study. Am J Ophthalmol. 2010 Jun;149(6):893-902. doi: 10.1016/j.ajo.2010.01.025. Epub 2010 May 8.

    PMID: 20451896BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Central Study Contacts

Mina A Besada, Resident

CONTACT

Ismail M Abdellatif, Professor

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 30, 2021

First Posted

June 10, 2021

Study Start

July 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations