NCT00434707

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2007

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2007

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 13, 2007

Status Verified

February 1, 2007

First QC Date

February 10, 2007

Last Update Submit

February 12, 2007

Conditions

GlaucomaCataract

Keywords

glaucomacataratsmall pupils

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals with visually significant cataracts and medically uncontrolled primary open angle, angle clsoure, exfolaitive glaucoma

You may not qualify if:

  • Complicated catracts and secondary glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

GlaucomaCataractMiosis

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesLens DiseasesPupil DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ramasami Krishnadas, MD

    Aravind Eye Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramasamy Krishnadas, MD

CONTACT

91 452 4356 118krishnadas@aravind.org

George Varghese Puthuran, MD

CONTACT

91 452 4356 118george@aravind.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2007

First Posted

February 13, 2007

Study Start

March 1, 2007

Study Completion

December 1, 2007

Last Updated

February 13, 2007

Record last verified: 2007-02