India Glaucoma Outcomes and Treatment Trial
| ISRCTN | ISRCTN52778666 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52778666 |
| Protocol serial number | N/A |
| Sponsor | Pfizer Inc. (USA) |
| Funder | Pfizer Inc. |
- 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
Scientific
Wilmer 120
600 N. Wolfe Street
Baltimore
21287
United States of America
| ncongdon@jhmi.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | India Glaucoma Outcomes and Treatment Trial |
| Study acronym | INGOTT |
| Study objectives | Surgery 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) studied | Glaucoma |
| Intervention | Medicine (timolol, latanaprost and brimonidine) versus surgery |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) | 1. Intraocular pressure 2. Visual acuity 3. Quality of life |
| Key secondary outcome measure(s) | Cataract grade |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 700 |
| Total final enrolment | 398 |
| Key inclusion criteria | Glaucoma patients over the age of 30 years in India |
| Key exclusion criteria | 1. Previous surgery 2. Intraocular pressure (IOP) >35 |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- India
- United States of America
Study participating centre
Wilmer 120
Baltimore
21287
United States of America
21287
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
