Orthoptic Changes Following Photorefractive Keratectomy

Phase 3

Completed

• Conditions: Orthoptic Changes
• Interventions: Procedure: Kerato refractive Surgery

• Registration Number: NCT01279993
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Purpose: To detect orthoptic changes in patients undergoing photorefractive keratectomy (PRK). Method: This interventional case series was performed on 297 eyes of 150 patients who were candidates for PRK. Complete ophthalmic evaluations focusing on orthoptic examinations were performed before and 3 months after PRK. Results: Before PRK, two (1.3%) patients had esotropia that remained unchanged postoperatively. However, 3 (2%) patients had distance exotropia preoperatively which improved after PRK. Of 12 cases (8%) with preoperative exotropia at near, 3 (2%) cases became orthophoric. Six patients (4%) developed postoperative near exotropia. A significant reduction in means of convergence and divergence amplitudes (P\<0.001) and a meaningful increase in mean of near point of convergence (NPC) (P\<0.006) were noticed after PRK. A reduction of ≥10 PD in convergence amplitude and ≥5 PD in divergence amplitude were detected in 10 and 5 patients, respectively. Four patients had an preoperative NPC\>10 cm which was not changed by the surgery. Out of 9 (6%) patients with baseline stereopsis \>60 seconds of arc, 2 (1.33%) cases showed an improvement in stereopsis following PRK. None of the patients complained of postoperative diplopia. Conclusion: Eye deviation in patients undergoing PRK may improve or remain unchanged after operation and postoperative deviations can develop following this surgery. Diminishing of fusional amplitude and increasing of NPC as well as improving of stereopsis may also happen after PRK. Therefore, a preoperative orthoptic examination in patients with any concerning histories and/or motility issues on routine exam is recommended before performing PRK.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-04
• Study Start: 2008-04
• Primary Completion: 2009-01
• Study Completion: 2009-04
• Study First Submitted: 2011-01-19
• Study First Submitted QC: 2011-01-19
• Last Update Submitted: 2011-01-19
• Study First Posted: 2011-01-20
• Last Update Posted: 2011-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

>18 yrs / refractive errors / with consent

Exclusion Criteria

< 18 / corneal opacity - keratoconus

Dry eye / diabetes / collages vacuolar disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Kerato refractive Surgery	Kerato refractive Surgery	-

Primary Outcome Measures

Name	Time	Method
orthoptic changes	before and after KRS	Prism / (deviation)

Secondary Outcome Measures

Name	Time	Method
VA , Streopsis , deviation , fusion , NPC	before and after KRS	Snellen , Titmus, prism, ruler

Trial Locations

Locations (1)

Labbafinejad medical center; 🇮🇷 Tehran, Iran, Islamic Republic of