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Contrast Sensitivity Assessment in Pediatric Cataract Surgery With IOL Implantation

Primary Purpose

Contrast Sensitivity

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Cataract Surgery
Sponsored by
Iladevi Cataract and IOL Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contrast Sensitivity focused on measuring Contrast Sensitivity , Pediatric Cataract Surgery,

Eligibility Criteria

1 Year - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children older than 4 years and lamellar and posterior subcapsular cataracts undergoing cataract surgery with IOL implantation

Exclusion Criteria:

  • eyes with traumatic or subluxated cataract,

Sites / Locations

  • Iladevi Cataract & IOL Research Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients undergoing cataract surgery

Arm Description

Outcomes

Primary Outcome Measures

Contrast Sensitivity at 3, 6, 12 and 18 cycles per degree under photopic and mesopic conditions pre and post cataract surgery
Preoperative and 1 and 3 months postoperatively contrast sensitivity testing would performed using the CSV 1000E sine wave grating test face (Vector Vision, USA) with the patient seated at a distance of 2.5 m from the chart. The test is performed after the patient was adapted to the room luminance for 5 minutes. The non viewing eye is occluded for each measurement, and the best spectacle refractive correction is placed in front of the viewing eye. Testing is performed at preoperative 3, 6, 12 and 18 cycles per degree, each spatial frequency being tested under two lighting conditions: photopic (85cd/m2) and mesopic (2.7cd/m2). The contrast sensitivity values are documented in log units. Sensitivity levels at each frequency range from 0.7 to 2.08 (3 cpd), 0.91 to 2.29 (6 cpd), 0.61 to 1.99 (12 cpd), and 0.17 to 1.55 (18 cpd) log units. This testing is performed with the patient wearing their refractive correction in form of spectacles.

Secondary Outcome Measures

Improvement in Best Corrected Snellen's Visual Acuity following Cataract Surgery
Corrected distance visual acuity (CDVA) which IS recorded in LogMAR units at preoperative and 1 and 3 months postoperatively. Monocular high-contrast Snellen visual assessment for distance would be done with the Early Treatment Diabetic Retinopathy Study chart (Vector Vision acuity chart at 100% contrast) with Corrected distance visual acuity CDVA at 4 m under photopic condition.

Full Information

First Posted
July 1, 2013
Last Updated
July 16, 2013
Sponsor
Iladevi Cataract and IOL Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01901744
Brief Title
Contrast Sensitivity Assessment in Pediatric Cataract Surgery With IOL Implantation
Official Title
Contrast Sensitivity Assessment in Pediatric Cataract Surgery With IOL Implantation: A Comparison of Preoperative and Early Postoperative Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iladevi Cataract and IOL Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study evaluates contrast sensitivity in older children following surgery for lamellar and posterior subcapsular cataracts. Often, pediatric surgeons tend to delay surgery in these children who present beyond the amblyogenic age group. These cataracts are often compatible with reasonable visual acuity and therefore some surgeons prefer to wait for surgery, whereas others tend to operate. The study evaluates improvement in contrast sensitivity at different spatial frequencies following cataract surgery for lamellar and posterior subcapsular cataracts in older children.
Detailed Description
All patients undergoes temporal clear corneal incision, manual anterior continuous curvilinear capsulorhexis, bimanual irrigation/aspiration for lens removal and residual cortex, posterior capsule management based on the age of the patient either manual posterior capsulorhexis (PCCC) upto 6 years or leaving intact posterior capsule and implantation of single-piece AcrySof SN60WF (Alcon Laboratories, Forth Worth, Texas) hydrophobic acrylic IOL in-the-bag. Postoperatively, all the patients are examined first for high contrast sensitivity and then for low contrast at 1 week, 1 and 3 months respectively. The results are analyzed for corrected distance visual acuity (CDVA) which is recorded in LogMAR units at preoperative and 1 and 3 months postoperatively. Monocular high-contrast Snellen visual assessment for distance is done with the Early Treatment Diabetic Retinopathy Study chart (Vector Vision acuity chart at 100% contrast) with Corrected distance visual acuity CDVA at 4 m under photopic condition. Similarly at preoperative and 1 and 3 months postoperatively contrast sensitivity testing is also performed using the CSV 1000E sine wave grating test face (Vector Vision, USA) with the patient seated at a distance of 2.5 m from the chart. The test is performed after the patient is adapted to the room luminance for 5 minutes. The non viewing eye was occluded for each measurement, and the best spectacle refractive correction is placed in front of the viewing eye. Testing is being tested under two lighting conditions: photopic (85cd/m2) and mesopic (2.7cd/m2). The contrast sensitivity values are documented in log units. Sensitivity levels at each frequency range from 0.7 to 2.08 (3 cpd), 0.91 to 2.29 (6 cpd), 0.61 to 1.99 (12 cpd), and 0.17 to 1.55 (18 cpd) log units. This testing is performed with the patient wearing their refractive correction in form of spectacles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Sensitivity
Keywords
Contrast Sensitivity , Pediatric Cataract Surgery,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients undergoing cataract surgery
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Cataract Surgery
Primary Outcome Measure Information:
Title
Contrast Sensitivity at 3, 6, 12 and 18 cycles per degree under photopic and mesopic conditions pre and post cataract surgery
Description
Preoperative and 1 and 3 months postoperatively contrast sensitivity testing would performed using the CSV 1000E sine wave grating test face (Vector Vision, USA) with the patient seated at a distance of 2.5 m from the chart. The test is performed after the patient was adapted to the room luminance for 5 minutes. The non viewing eye is occluded for each measurement, and the best spectacle refractive correction is placed in front of the viewing eye. Testing is performed at preoperative 3, 6, 12 and 18 cycles per degree, each spatial frequency being tested under two lighting conditions: photopic (85cd/m2) and mesopic (2.7cd/m2). The contrast sensitivity values are documented in log units. Sensitivity levels at each frequency range from 0.7 to 2.08 (3 cpd), 0.91 to 2.29 (6 cpd), 0.61 to 1.99 (12 cpd), and 0.17 to 1.55 (18 cpd) log units. This testing is performed with the patient wearing their refractive correction in form of spectacles.
Time Frame
up to 3 months postoperatively
Secondary Outcome Measure Information:
Title
Improvement in Best Corrected Snellen's Visual Acuity following Cataract Surgery
Description
Corrected distance visual acuity (CDVA) which IS recorded in LogMAR units at preoperative and 1 and 3 months postoperatively. Monocular high-contrast Snellen visual assessment for distance would be done with the Early Treatment Diabetic Retinopathy Study chart (Vector Vision acuity chart at 100% contrast) with Corrected distance visual acuity CDVA at 4 m under photopic condition.
Time Frame
1 and 3 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children older than 4 years and lamellar and posterior subcapsular cataracts undergoing cataract surgery with IOL implantation Exclusion Criteria: eyes with traumatic or subluxated cataract,
Facility Information:
Facility Name
Iladevi Cataract & IOL Research Centre
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380 052
Country
India

12. IPD Sharing Statement

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Contrast Sensitivity Assessment in Pediatric Cataract Surgery With IOL Implantation

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