Comparison of Pre-operative Measurements With Intraoperative Aberrometry in Predicting Correction for Low Toric Lens Correction in Cataract Surgery

Cataract Surgery Clinical Trial

Official title:

Comparison of Pre-operative Measurements With Intraoperative Aberrometry in Predicting Needed Correction for Low Toric Lens Correction in Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04247152
• Other study ID #: 1909 ORA vs Biometry
• Status: Completed
• Phase: N/A
• Start date: July 22, 2019
• Est. completion date: September 25, 2019

Study information

• Verified date: January 2020
• Source: Research Insight LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Examination of the accuracy of toric predictive power in patients with 1.5 diopters of astigmatism or less.

Description:

Based on preoperative keratometry and using the Baylor Nomogram and a standard factor for surgically-induced astigmatism, the investigators will calculate "keratometry-based total astigmatism" for each patient. This will be compared to "aberrometry-based total astigmatism", i.e. the total astigmatism measured by ORA in each case. With this information the investigators will determine in what portion of patients keratometry-based total astigmatism vs aberrometry-based total astigmatism predicts a need for astigmatism correction, (i.e., total astigmatism is greater than or equal to 0.5 D) during cataract surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 25, 2019
• Est. primary completion date: September 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who underwent conventional (non-femtosecond) cataract surgery and whose "data to be collected" are accessible and available from the ORA database.

• Patients whose medical records show they did not exhibit any significant ocular morbidity that would be expected to influence outcome measures.

Exclusion Criteria:

• Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their visual outcome or ability to be refracted after.

• Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.)

• Patients with previous refractive surgery.

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery

Intervention

Other:
• Intraoperative Aberrometry vs preoperative biometry
Hypothesis: Intraoperative aberrometry measures lower levels of astigmatism more accurately than preoperative biometry in patients undergoing cataract surgery.

Locations

Country	Name	City	State
United States	Harvard Eye Associates	Laguna Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Research Insight LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients requiring Astigmatism Correction	Proportion of patients requiring astigmatism correction, i.e., having need for astigmatism correction of greater than or equal to 0.5 D during cataract surgery, when measured by preoperative keratometry vs intraoperative aberrometry.	up to 3 months
Secondary	Patients with Postoperative residual astigmatism 0.5 to 1.0 diopter	Looking at patients whose ORA-based total astigmatism was greater than or equal to 0.5 and less than or equal to 1.0 diopter, did patients receiving astigmatism correction have less postoperative residual astigmatism than those who did not receive astigmatism correction?	up to 3 months
Secondary	Patients with Postoperative residual astigmatism 1.0 to 1.5 diopter	Looking at patients whose ORA-based total astigmatism was greater than 1.0 and less than or equal to 1.5 diopter,m did patients receiving astigmatism correction have less postoperative residual astigmatism than those who did not receive astigmatism correction?	up to 3 months