Skip to main content
OpenTrials
Completed

NCT Number: NCT01279993

Orthoptic Changes Following Photorefractive Keratectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Labbafinejad medical center

Tehran, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

>18 yrs / refractive errors / with consent

Exclusion criteria

< 18 / corneal opacity - keratoconus

Dry eye / diabetes / collages vacuolar disease

Treatment and study plan

Kerato refractive Surgery

Procedure

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.

Primary outcomes

  1. orthoptic changes

    Time frame: before and after KRS

    Prism / (deviation)

Secondary outcomes

  1. VA , Streopsis , deviation , fusion , NPC

    Time frame: before and after KRS

    Snellen , Titmus, prism, ruler

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 20, 2011
Registry last updated
Jan 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.