Contrast Sensitivity Assessment in Pediatric Cataract Surgery With IOL Implantation

Contrast Sensitivity Assessment in Pediatric Cataract Surgery With IOL Implantation: A Comparison of Preoperative and Early Postoperative Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Contrast Sensitivity
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380 052
      • Iladevi Cataract & IOL Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients undergoing cataract surgery	Procedure: Cataract Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 and 3 months postoperatively

Collaborators and Investigators

• Sponsor: Iladevi Cataract and IOL Research Center

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: July 1, 2013
• First Submitted That Met QC Criteria: July 16, 2013
• First Posted (ESTIMATE): July 17, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 17, 2013
• Last Update Submitted That Met QC Criteria: July 16, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Contrast Sensitivity , Pediatric Cataract Surgery,
• Additional Relevant MeSH Terms: Immune System Diseases; Eye Diseases; Lens Diseases; Hypersensitivity; Cataract
• Other Study ID Numbers: 12-008