GlaucomaNCT00434707
Outcome of Small Pupil Phacotrabeculectomy in Persons With Glaucoma and Cataract
An observational study of Glaucoma and Cataract, run by Aravind Medical Research Foundation.
Trial summary
Small pupils are not uncommon in situations requiring surgical intervention for glaucoma and cataract. Inadequate binocular view during combined trabeculaectomy and glaucoma surgery needs to be overcome by additional iris manupulations to dilate the pupils which increase the liklihood of inflammation, inraocular… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with visually significant cataracts and medically uncontrolled primary open angle, angle clsoure, exfolaitive glaucoma
Who cannot join
- Complicated catracts and secondary glaucoma
Trial locations and contacts
No sites are listed yet.
About this study
Small pupils are not uncommon in situations requiring surgical intervention for glaucoma and cataract. Inadequate binocular view during combined trabeculaectomy and glaucoma surgery needs to be overcome by additional iris manupulations to dilate the pupils which increase the liklihood of inflammation, inraocular pressure rise after surgery and enhnced liklihood of failure of glaucoma surgery. The proposed trial is an observational study to analyse post operative outcome of eyes undrgoing trabeculectomy and phacoemulsification with intraocular lens implantation with small pupils in persons with glaucoma coexisting with cataract.
Read the detailed description
Small pupils are not uncommon in situations requiring surgical intervention for glaucoma and cataract. Inadequate binocular view during combined trabeculaectomy and glaucoma surgery needs to be overcome by additional iris manupulations to dilate the pupils which increase the liklihood of inflammation, inraocular pressure rise after surgery and enhnced liklihood of failure of glaucoma surgery. The proposed trial is an observational study to analyse post operative outcome of eyes undrgoing trabeculectomy and phacoemulsification with intraocular lens implantation with small pupils in persons with glaucoma coexisting with cataract
- Keywords
- glaucoma, catarat, small pupils
- Medical subject headings
- Glaucoma, Cataract, Miosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startMar 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Aravind Medical Research Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Ramasami Krishnadas, MD, Principal investigator, Aravind Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434707
- Sponsor's protocol ID
- SPTRIPLE0001
- Status last verified
- Feb 2007
- First submitted
- 10 Feb 2007
- Last updated
- 13 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Small Pupil Phacotrabeculectomy in Persons With Glaucoma and Cataract
- ClinicalTrials.gov ID
- NCT00434707
- Acronym / sponsor ID
- SPTRIPLE0001
- Keywords
- glaucoma, catarat, small pupils
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants
- Lead sponsor
- Aravind Medical Research FoundationUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- Dec 2007
- First posted
- 13 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Small pupils are not uncommon in situations requiring surgical intervention for glaucoma and cataract. Inadequate binocular view during combined trabeculaectomy and glaucoma surgery needs to be overcome by additional iris manupulations to dilate the pupils which increase the liklihood of inflammation, inraocular pressure rise after surgery and enhnced liklihood of failure of glaucoma surgery. The proposed trial is an observational study to analyse post operative outcome of eyes undrgoing trabeculectomy and phacoemulsification with intraocular lens implantation with small pupils in persons with glaucoma coexisting with cataract.
Detailed description
Small pupils are not uncommon in situations requiring surgical intervention for glaucoma and cataract. Inadequate binocular view during combined trabeculaectomy and glaucoma surgery needs to be overcome by additional iris manupulations to dilate the pupils which increase the liklihood of inflammation, inraocular pressure rise after surgery and enhnced liklihood of failure of glaucoma surgery. The proposed trial is an observational study to analyse post operative outcome of eyes undrgoing trabeculectomy and phacoemulsification with intraocular lens implantation with small pupils in persons with glaucoma coexisting with cataract
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with visually significant cataracts and medically uncontrolled primary open angle, angle clsoure, exfolaitive glaucoma
Key exclusion criteria (1 listed)
- Complicated catracts and secondary glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramasami Krishnadas, MD principal investigator
Aravind Eye Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Cataract, run by Aravind Medical Research Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramasamy Krishnadas, MD (91 452 4356 118, krishnadas@aravind.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2007.