Contrast Sensitivity Assessment in Pediatric Cataract Surgery With IOL Implantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abhay R. Vasavada, Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier:
NCT01901744
First received: July 1, 2013
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Contrast Sensitivity
Procedure: Cataract Surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Contrast Sensitivity Assessment in Pediatric Cataract Surgery With IOL Implantation: A Comparison of Preoperative and Early Postoperative Outcomes

Resource links provided by NLM:


Further study details as provided by Iladevi Cataract and IOL Research Center:

Primary Outcome Measures:
  • Contrast Sensitivity at 3, 6, 12 and 18 cycles per degree under photopic and mesopic conditions pre and post cataract surgery [ Time Frame: up to 3 months postoperatively ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 and 3 months postoperatively ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: January 2009
Study Completion Date: January 2013
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients undergoing cataract surgery Procedure: Cataract Surgery

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.

  Eligibility

Ages Eligible for Study:   1 Year to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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,
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01901744

Locations
India
Iladevi Cataract & IOL Research Centre
Ahmedabad, Gujarat, India, 380 052
Sponsors and Collaborators
Iladevi Cataract and IOL Research Center
  More Information

No publications provided

Responsible Party: Abhay R. Vasavada, Director, Iladevi Cataract and IOL Research Center, Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier: NCT01901744     History of Changes
Other Study ID Numbers: 12-008
Study First Received: July 1, 2013
Last Updated: July 16, 2013
Health Authority: India: Data Monitoring Committee

Keywords provided by Iladevi Cataract and IOL Research Center:
Contrast Sensitivity , Pediatric Cataract Surgery,

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 20, 2014