ISRCTN ISRCTN52778666
DOI https://doi.org/10.1186/ISRCTN52778666
Secondary identifying numbers N/A
Submission date
11/10/2005
Registration date
30/03/2006
Last edited
11/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nathan Congdon
Scientific

Wilmer 120
600 N. Wolfe Street
Baltimore
21287
United States of America

Email ncongdon@jhmi.edu

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleIndia Glaucoma Outcomes and Treatment Trial
Study acronymINGOTT
Study objectivesSurgery will be more effective than medicines in controlling glaucoma in India
Ethics approval(s)Approved by the Internal Review Boards at the Johns Hopkins University, Baltimore, USA and the Aravind Eye Hospital in India
Health condition(s) or problem(s) studiedGlaucoma
InterventionMedicine (timolol, latanaprost and brimonidine) versus surgery
Intervention typeProcedure/Surgery
Primary outcome measure1. Intraocular pressure
2. Visual acuity
3. Quality of life
Secondary outcome measuresCataract grade
Overall study start date01/01/2003
Completion date01/01/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants700
Total final enrolment398
Key inclusion criteriaGlaucoma patients over the age of 30 years in India
Key exclusion criteria1. Previous surgery
2. Intraocular pressure (IOP) >35
Date of first enrolment01/01/2003
Date of final enrolment01/01/2007

Locations

Countries of recruitment

  • India
  • United States of America

Study participating centre

Wilmer 120
Baltimore
21287
United States of America

Sponsor information

Pfizer Inc. (USA)
Industry

Corporate Headquarters
New York
20001
United States of America

ROR logo "ROR" https://ror.org/01xdqrp08

Funders

Funder type

Industry

Pfizer Inc.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2012 11/01/2021 Yes No

Editorial Notes

11/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.